| Literature DB >> 25110856 |
Anthony A Bamigboye1, G Justus Hofmeyr.
Abstract
BACKGROUND: Caesarean section is a very common surgical procedure worldwide. Suturing the peritoneal layers at caesarean section may or may not confer benefit, hence the need to evaluate whether this step should be omitted or routinely performed.Entities:
Mesh:
Year: 2014 PMID: 25110856 PMCID: PMC4448220 DOI: 10.1002/14651858.CD000163.pub2
Source DB: PubMed Journal: Cochrane Database Syst Rev ISSN: 1361-6137
Figure 1'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 2'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Analysis 1 1Comparison 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, Outcome 1 Postoperative adhesions.
Analysis 1 8Comparison 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, Outcome 8 Operating time (minutes).
Analysis 1 9Comparison 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, Outcome 9 Postoperative days in hospital.
Analysis 1 10Comparison 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, Outcome 10 Chronic pelvic pain.
Analysis 2 5Comparison 2 Non-closure of visceral peritoneum only versus closure of both peritoneal layers, Outcome 5 Operating time (minutes).
Analysis 2 6Comparison 2 Non-closure of visceral peritoneum only versus closure of both peritoneal layers, Outcome 6 Postoperative days in hospital.
Analysis 2 3Comparison 2 Non-closure of visceral peritoneum only versus closure of both peritoneal layers, Outcome 3 Postoperative fever.
Analysis 2 2Comparison 2 Non-closure of visceral peritoneum only versus closure of both peritoneal layers, Outcome 2 Wound infection.
Analysis 2 4Comparison 2 Non-closure of visceral peritoneum only versus closure of both peritoneal layers, Outcome 4 Endometritis.
Analysis 3 5Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 5 Operating time (minutes).
Analysis 3 2Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 2 Postoperative pain.
Analysis 3 7Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 7 Mobilisation time in hours (not prespecified outcome).
Analysis 3 8Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 8 Time to oral intake in hours (not prespecified outcome).
Analysis 3 9Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 9 Drop in haemoglobin g/dL (not prespecified outcome).
Analysis 3 10Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 10 Blood loss (not prespecified outcome).
Analysis 3 11Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 11 Time to flatus (not prespecified outcome).
Analysis 3 12Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 12 Wound pain, day 1 (visual analogue score).
Analysis 3 13Comparison 3 Non-closure of parietal peritoneum only versus closure of both peritoneal layers, Outcome 13 Persistent abdominal pain after 8 months (numerical rating scale).
Analysis 4 1Comparison 4 Non closure versus closure of visceral peritoneum when parietal peritoneum is closed, Outcome 1 Urinary frequency at 8 weeks.
Analysis 4 2Comparison 4 Non closure versus closure of visceral peritoneum when parietal peritoneum is closed, Outcome 2 Urgency of urination.
Analysis 4 3Comparison 4 Non closure versus closure of visceral peritoneum when parietal peritoneum is closed, Outcome 3 Stress incontinence.
Figure 3Funnel plot of comparison: 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, outcome: 1.2 Wound infection.
Figure 4Funnel plot of comparison: 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, outcome: 1.6 Infectious morbidity.
Figure 5Funnel plot of comparison: 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, outcome: 1.8 Operating time (minutes).
Figure 6Funnel plot of comparison: 1 Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers, outcome: 1.9 Postoperative days in hospital.
| Date | Event | Description |
|---|---|---|
| 1 November 2013 | New citation required and conclusions have changed |
Fifteen new trials were incorporated (Altinbas |
| 1 November 2013 | New search has been performed | Search updated. Methods updated. |
| Dat | Event | Description |
|---|---|---|
| 2 December 2009 | Amended | Search updated. Fourteen new reports added to Studies awaiting classification. |
| 25 June 2008 | Feedback has been incorporated | Feedback from Peter Wein added. |
| 23 June 2008 | Amended | Converted to new review format. |
| 1 December 2006 | New search has been performed |
Search updated. We identified nine new trials; five have been included and four excluded. The inclusion of the new trials has not changed the conclusions. |
| 1 July 2003 | New citation required and conclusions have changed | Substantive amendment |
Altinbas 2013
| Methods | Randomised trial. | |
| Participants | Women for caesarean section. | |
| Interventions | 55 women were randomised to have caesarean section with closure of parietal peritoneum and 55 women had non-closure of the peritoneum. | |
| Outcomes | Drop in haemoglobin, blood loss, extra suture needed, operating time, time to passage of flatus, immobilisation, oral intake and postoperative pain. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Concealed envelope. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Impossible to blind a surgical procedure. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss found. |
| Selective reporting (reporting bias) | Low risk | No bias. |
| Random sequence generation (selection bias) | Unclear risk | Method of generation, not stated. |
| Other bias | Low risk | No obvious bias noted. |
Anteby 2009
| Methods | A prospective randomised trial. | |
| Participants | 533 women at term who were caesarean section naive. | |
| Interventions | Closure versus non-closure of peritoneum at caesarean section. | |
| Outcomes | Short-term outcomes of analgesic need, febrile illness and surgical wound infection. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Random allocation but no mention of the method of concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data of all women were included. |
| Selective reporting (reporting bias) | Low risk | None observed. |
| Random sequence generation (selection bias) | Low risk | Computer-generated sequence. |
| Other bias | Low risk | None. |
CAESAR 2010
| Methods | This is a multicentre, randomised controlled trial of techniques of performing caesarean section. | |
| Participants | 30,033 women undergoing caesarean delivery. | |
| Interventions | Single versus double layer uterine closure; closure of the peritoneum and the use of sub rectus sheath drain. | |
| Outcomes | Febrile infectious morbidity. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Low risk | Telephonic allocation. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collectors and analyst were blinded but the surgeon could not be blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The analysed women were only those who have any follow-up data. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated randomisation. |
| Other bias | Low risk | None. |
Chanrachakul 2002
| Methods | Allocation was made randomly using sealed opaque envelopes in computer-generated random sequence. | |
| Participants | 60 women to undergo caesarean section. | |
| Interventions | 1. Experimental (30): non-closure of both peritoneal surfaces.2. Control (30): closure of both peritoneal surfaces. | |
| Outcomes | Operating time, intraoperative blood loss, length of hospitalisation and analgesic doses required. | |
| Notes | No difference in the amount of analgesic dosages required. | |
| Allocation concealment (selection bias) | Low risk | Allocation by sealed opaque envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Surgeon could not be blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss of data. |
| Selective reporting (reporting bias) | Low risk | None noted. |
| Random sequence generation (selection bias) | Low risk | Computer generated. |
| Other bias | Low risk | None. |
CORONIS 2013
| Methods | Fractional, factorial trial. | |
| Participants | 15,935 women for caesarean section. | |
| Interventions | 1 of the 5 intervention pairs was closure versus non-closure of peritoneum of parietal and visceral peritoneum. | |
| Outcomes | Maternal mortality, infectious morbidity, further operative procedures, blood transfusion of more than 1 unit within 6 weeks of follow-up. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Envelopes which contain allocation sheet. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Surgeons could not be masked but unlikely to affect the outcome as in most surgical procedures. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Percentage of data loss was low. |
| Selective reporting (reporting bias) | Unclear risk | None. |
| Random sequence generation (selection bias) | Low risk | Web-based randomisation. |
| Other bias | Unclear risk | Unclear. |
Galaal 2000
| Methods | Prospective randomised trial. Allocation by numbered envelope technique. | |
| Participants | 60 women undergoing caesarean section. | |
| Interventions | 1. 30 women in the experimental group: non-closure of both peritoneal surfaces.2. 30 women with both peritoneal surfaces closed serving as controls. | |
| Outcomes | Operating time, length of stay, blood loss, blood transfusion, drop in haemoglobin, postoperative pyrexia, and wound infection. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Adequate by sealed numbered envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Cannot be blinded but data collection blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Random allocation. |
| Other bias | Low risk | None noted. |
Gemer 2006
| Methods | Prospective randomised trial. | |
| Participants | 387 women at term were randomised. | |
| Interventions | Closure versus non-closure. | |
| Outcomes | Short-term outcomes - duration of surgery analgesic usage and febrile morbidity. | |
| Notes | This trial appears to precede the CORONIS trial. | |
| Allocation concealment (selection bias) | Unclear risk | No details. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information. |
| Selective reporting (reporting bias) | Low risk | No details to suggest reporting was biased. |
| Random sequence generation (selection bias) | Unclear risk | Only the abstract could be obtained. |
| Other bias | Unclear risk | No information. |
Ghahiry 2012
| Methods | Randomised trial. | |
| Participants | 108 women undergoing caesarean section. | |
| Interventions | 52 women undergoing caesarean section randomised into the Misgav Ladach and 60 women randomised into traditional Pfannenstiel incision. | |
| Outcomes | Filmy and dense adhesions formation and chronic pelvic pain. | |
| Notes | ||
| Allocation concealment (selection bias) | Unclear risk | Method of allocation not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete. |
| Selective reporting (reporting bias) | Low risk | No evidence of bias. |
| Random sequence generation (selection bias) | Unclear risk | Method of generation, not stated. |
| Other bias | Unclear risk | None. |
Ghongdemath 2011
| Methods | Prospective randomised study. | |
| Participants | 200 women undergoing caesarean section. | |
| Interventions | Closure versus non-closure of the peritoneum. | |
| Outcomes | Operative time, pain score, febrile illness, wound infection and hospital stay. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Opaque envelope. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collectors and analysts blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data completed. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated sequence. |
| Other bias | Low risk | None. |
Grundsell 1998
| Methods | A random-selection table was used to assign groups. | |
| Participants | 361 women "who were to undergo caesarean section". | |
| Interventions | 1. Experimental (179): both visceral and parietal peritoneum were left unclosed.2. Control (182): both visceral and parietal peritoneum were closed with a running, delayed absorbable suture. | |
| Outcomes | Operating time, febrile morbidity, wound infection, urinary tract infection, fever of unknown origin, wound dehiscence, opening of bowels, admission days and postoperative paralytic ileus. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Unclear as to how allocation was concealed. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of data collectors. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No data loss. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Random generated tables. |
| Other bias | Low risk | None. |
Hojberg 1998
| Methods | Telephone-randomisation via a computer program. | |
| Participants | 40 women referred for elective caesarean section. | |
| Interventions | 1. 21 women with non-closure of parietal peritoneum and closure of visceral peritoneum.2. 19 women had both peritoneal surfaces closed. | |
| Outcomes | Analgesic requirement (less used in non-closure group, data not included as non-parametric data given), blood loss, febrile morbidity, return of bowel action and days in hospital. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Adequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of assessors. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Telephone random sequence. |
| Other bias | Low risk | None. |
Huchon 2005
| Methods | Randomised trial. | |
| Participants | 240 women for caesarean section. 138 randomised. | |
| Interventions | Closure versus non-closure of the peritoneum for caesarean section. 63 women versus 75 women respectively. | |
| Outcomes | Wound infection, haematoma, time for ileus,durations of surgery and hospitalisation, postoperative pain and analgesic requirements. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Randomised but method not stated. |
| Other bias | Low risk | None. |
Hull 1991
| Methods | Allocation based on last digit of medical record. | |
| Participants | 113 women "who were to undergo caesarean section". | |
| Interventions | 1. Experimental (54): both visceral and parietal peritoneum were left unsutured. 2. Control (59): both the visceral and parietal peritoneum were closed with a running, delayed absorbable suture. | |
| Outcomes | Operating time, postoperative morbidity, hospital stay. | |
| Notes | 4 women excluded because had vertical uterine incisions. | |
| Allocation concealment (selection bias) | High risk | Inadequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Impossible to blind the surgeon but outcome assessors blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | High risk | Allocation based on last digit of medical record. |
| Other bias | Low risk | None. |
Irion 1996
| Methods | Random allocation in blocks of varying size at the beginning of the operation by computer-generated random numbers. Sequentially numbered opaque sealed envelopes were used. | |
| Participants | 280 women "were recruited" undergoing elective or emergency caesarean section. | |
| Interventions | 1. Experimental (137): both the visceral and parietal peritoneum were left unsutured.2. Control (143): both the visceral and parietal peritoneum were re-approximated using continuous, running, delayed absorbable sutures. | |
| Outcomes | Length of postoperative hospital stay (from operation notes), pain (visual analogue scale, analgesics on first postoperative day), duration of ileus (auscultation of bowel sounds) and febrile morbidity (sublingual temperature > 38 degrees centigrade lasting at least 24 hours). 7 years following the clinical study, a cohort of this women were contacted to assess the long-term follow-up (Roset E et al) Assessment for postsurgical adhesions and subfertility amongst others were made. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Sequentially-labelled opaque envelope. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Surgeon could not be blinded but the assessors. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Unclear risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated random sequence. |
| Other bias | Low risk | None. |
Kapustian 2012
| Methods | Randomised controlled trial. | |
| Participants | 533 women undergoing caesarean section. | |
| Interventions | Closure versus non-closure of peritoneum. | |
| Outcomes | Adhesions were scored in repeat caesarean section. | |
| Notes | ||
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Surgeon was blinded during repeat caesarean section. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated sequence. |
| Other bias | Low risk | None. |
Komoto 2005
| Methods | Pseudo-randomisation. | |
| Participants | Women undergoing caesarean section. | |
| Interventions | Closure of both peritoneal layers versus non-closure. | |
| Outcomes | Operative time and number of analgesic doses required. | |
| Notes | ||
| Allocation concealment (selection bias) | Unclear risk | Unknown. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Non-closure, 53 versus 70 closure. |
| Selective reporting (reporting bias) | Unclear risk | Not evident. |
| Random sequence generation (selection bias) | High risk | Hospital record. |
| Other bias | Unclear risk | Unknown. |
Malomo 2006
| Methods | Prospective randomised trial of uncomplicated women at term. | |
| Participants | 54 women who required delivery by caesarean section. | |
| Interventions | Closure versus non-closure of both visceral and parietal peritoneum. | |
| Outcomes | Anaesthetic time, duration of operation, analgesic requirement, wound infection and ileus. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Low risk | Opaque envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Table of random numbers was used. |
| Other bias | Low risk | None. |
Malvasi 2009
| Methods | Prospective randomised trial. | |
| Participants | Women who consented for elective caesarean section and for a repeat caesarean section in their next pregnancy. | |
| Interventions | Closure of visceral peritoneum versus non-closure. | |
| Outcomes | Adhesions formation using the adhesions scoring system, fibrosis and neoangiogenesis of mesothelial cells under electron microscopy. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | No mention of the method used to conceal initial allocation of women during repeat caesarean section. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes were clearly sought for and documented. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Patients 'were consecutively allocated into 2 groups by the clinicians....'. method of allocation was not stated. |
| Other bias | Low risk | None. |
Moraes 1999
| Methods | Prospective pseudo-randomised trial. | |
| Participants | 698 pregnant women for caesarean section. | |
| Interventions | Closure versus non-closure of both peritoneal layers. | |
| Outcomes | Duration of surgery, number of sutures used, postoperative pyrexia, wound infection, number of doses of analgesic, antiemetic and antiseptic requirement, and number of days spent in the hospital. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Method of concealment not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Surgeon not blinded but would not have affected the result. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete data. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | High risk | Sequential allocation. |
| Other bias | Low risk | None. |
Nagele 1996
| Methods | Pseudo-randomised based on days of the week. | |
| Participants | 549 women undergoing caesarean section were randomised. | |
| Interventions | 262 non-closure versus 287 closure visceral peritoneum. | |
| Outcomes | Operating time, postoperative morbidity, hospital stay. | |
| Notes | None. | |
| Allocation concealment (selection bias) | High risk | Inadequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | High risk | Pseudo-randomisation. |
| Other bias | Low risk | None. |
Pietrantoni 1991
| Methods | Allocation by last digit of hospital number (odd or even). | |
| Participants | 248 women undergoing caesarean section through a Pfannenstiel incision. | |
| Interventions | 1. Experimental (127): non-closure of parietal peritoneum but closure of the visceral peritoneum.2. Control (121): both visceral and parietal peritoneum were sutured. | |
| Outcomes | Postoperative morbidity, days in hospital. Standard errors of the mean converted to standard deviation for this analysis. | |
| Notes | 6 women were excluded. | |
| Allocation concealment (selection bias) | High risk | Inadequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | High risk | Allocation by using hospital number. |
| Other bias | Low risk | None. |
Rafique 2002
| Methods | Randomised controlled trial. Randomisation generated by computer and allocation by opaque sealed numbered envelopes. | |
| Participants | 100 women undergoing caesarean section. | |
| Interventions | 1. Experimental group, non-closure: 50. 2. Control group: 50. | |
| Outcomes | Operative time, number of days to discharge, postoperative haemoglobin, use of analgesia. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Low risk | Adequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not blinded but surgeon could not have been blinded. Assessor blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated random sequence. |
| Other bias | Low risk | None. |
Saha 2001
| Methods | Randomised controlled trial. Method of randomisation not stated. | |
| Participants | 100 women undergoing caesarean section. | |
| Interventions | 1. Experimental group, non-closure: 50. 2. Control group: 50 women who had non-closure of visceral peritoneum. | |
| Outcomes | Operative time, number of days to discharge, postoperative febrile illness, use of additional narcotics analgesia. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Not stated. |
| Other bias | Low risk | None. |
Shahin 2009
| Methods | Prospective randomised trial. | |
| Participants | Women at term, who consented to caesarean section and in the trial. | |
| Interventions | 170 randomised to have the parietal peritoneum closed and 170 were left unclosed. Visceral peritoneum was closed in all women. 325 women were analysed. | |
| Outcomes | Postoperative abdominal pain, epigastric pain and wound pain. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Outcomes were incomplete. 15 women were not analysed. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Low risk | Computer-generated random sequence. |
| Other bias | Low risk | None. |
Shahin 2010
| Methods | Randomised trial. | |
| Participants | Women for caesarean section. | |
| Interventions | Closure of parietal peritoneum versus non-closure. | |
| Outcomes | Postoperative urinary symptoms assessed up to 6 months. | |
| Notes | ||
| Allocation concealment (selection bias) | Low risk | Opaque envelopes. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor of outcome not aware of allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 285 women in the non-closure versus 290. All studied women were assessed for outcome. |
| Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
| Random sequence generation (selection bias) | Low risk | Computer based. |
| Other bias | Unclear risk | None noted. |
Sood 2004
| Methods | Randomised controlled trial. Method of randomisation not stated. | |
| Participants | 149 women undergoing caesarean section. | |
| Interventions | 1. Experimental (71): non-closure of both parietal and visceral peritoneum.2. Control (78): both visceral and parietal peritoneum were closed. | |
| Outcomes | Anaesthesia time, operating time, postoperative pain, no of analgesic doses, febrile morbidity, endomyometritis, cystitis, wound infection and days of hospitalisation. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Unclear. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of assessor. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Not stated. |
| Other bias | Low risk | None. |
Tuncer 2003
| Methods | Randomised controlled trial. Method of randomisation not stated. | |
| Participants | 80 women undergoing caesarean section. | |
| Interventions | 1. 40 women with non-closure of parietal peritoneum and visceral peritoneum.2. 40 women had both peritoneal surfaces closed. | |
| Outcomes | Operative time, anaesthesia time, length of hospital stay, morphine consumption and visual analogue pain scores. | |
| Notes | ||
| Allocation concealment (selection bias) | Unclear risk | Unclear. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation, unknown. |
| Other bias | Low risk | None. |
Weerawetwat 2004
| Methods | "Each surgeon randomised and separated the women by running number into 3 groups." | |
| Participants | 360 women undergoing caesarean section. | |
| Interventions | 3 groups: non-closure of both peritoneum, closure of only parietal peritoneum, closure of both peritoneum. | |
| Outcomes | Short- and long-term assessments including adhesions at repeat caesarean section. | |
| Notes | An important study that looks at the issue of adhesions during repeat caesarean section. | |
| Allocation concealment (selection bias) | High risk | Inadequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Yes. |
| Other bias | Low risk | None. |
Zhang 2000
| Methods | Randomised controlled trial. Method of randomisation not stated. | |
| Participants | Pregnant women 36-43 weeks undergoing caesarean section. | |
| Interventions | Peritoneal non-closure in 158 women compared with 160 women with closure. | |
| Outcomes | Postoperative morbidity, bowel movement, analgesic requirement, infection, Apgar score, neonatal outcome. | |
| Notes | None. | |
| Allocation concealment (selection bias) | Unclear risk | Not known. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of information. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | To assessor. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome was complete. |
| Selective reporting (reporting bias) | Low risk | None. |
| Random sequence generation (selection bias) | Unclear risk | Not clear. |
| Other bias | Low risk | None. |
| Study | Reason for exclusion |
|---|---|
| Ayres-de-Campos 2000 | No data on the control group given. Information on the first 37 cases assigned to the experimental non-closure group was available. |
| Balat 2000 | Excluded because intervention include non-closure of the rectus muscle and subcutaneous fascia, as well as peritoneum. Allocation was made 'randomly' (using odd and even days).Participants: 266 women undergoing caesarean section.Interventions:1. Experimental (134), both visceral and parietal peritoneum and rectus muscle and subcutaneous fascia were unsutured.2. Control (132), all layers were sutured.Outcomes: operation time, hospitalisation time and postoperative complications. |
| Behrens 1997 | Allocation was effected in alternating order; no adequate randomisation and lack of data. |
| Bjorklund 2000 | Excluded because several aspects of caesarean section were compared, not only peritoneal non-closure. Allocation was based on last digit of medical record. 339 women "who were to undergo caesarean section" were enrolled.1. Experimental (169) Misgav-Ladach technique, both visceral and parietal peritoneum were left unsutured. 2. Control (170) routine technique, both the visceral and parietal peritoneum were closed. Outcomes: Apgar scores at 5 and 10 minutes, postoperative course and use of antibiotics, number of sutures used, febrile morbidity, wound infection, urinary tract infection, wound dehiscence, opening of bowels, admission days and postoperative ileus. |
| Chaudri 2009 | This is a poster presentation that has no outcome data. |
| Dani 1998 | This study did not demonstrate any difference in short-term outcome of newborn infants born by caesarean section whether the peritoneal surfaces are closed or not. Exclusion is on the basis of the outcome reported not being in the protocol. |
| Darj 1999 | Excluded because the whole Misgav-Ladach technique was compared with the Pfannenstiel method. Random allocation.Participants: 50 women undergoing caesarean section electively.Interventions:1. Experimental group, Joel-Cohen technique including non-closure of peritoneal surfaces (25).2. Control group with Pfannenstiel technique and closure of both peritoneal surfaces (25).Outcomes: duration of operation, amount of bleeding, analgesic doses required, scar appearance, and length of hospitalisation. |
| Decavalas 1997 | This well-conducted randomised trial was ambiguous as to whether the peritoneum was closed in the control Pfannenstiel group. It appears that the outcome measured was the technique of opening the abdomen and may not evaluate closure versus non-closure of peritoneum even though the original description of Pfannenstiel includes closure of peritoneal surfaces. This may therefore not be assumed. Letters have been written to the author for clarification but no response as at November 2006. |
| Ferrari 2001 | Excluded because whole Misgav-Ladach technique compared with Pfannenstiel. Allocation was made randomly using sealed envelopes.Participants: 158 women to undergo caesarean section.Interventions:1. Experimental (83), Joel-Cohen technique including non-closure of both peritoneal surfaces and single layered closure of uterine incision.2.Control (75), Pfannenstiel technique with closure of both peritoneal surfaces.Outcomes: operating time, extraction time, intra-operative blood loss, length of hospitalisation, total sutures used. |
| Franchi 1998 | Excluded because intervention included Joel-Cohen incision as well as peritoneal non-closure.Allocation was made "randomly".Participants: 299 women to undergo caesarean section.Interventions:1. Experimental (149), Joel-Cohen incision and non-closure of both peritoneal surfaces.2. Control (150), Pfannenstiel incision and closure of both peritoneal surfaces.Outcomes: operating time, intraoperative blood loss, blood transfusion, bladder injuries, wound dehiscence, endometritis, sepsis, febrile morbidity, and urinary tract infections. |
| Gaucherand 2001 | Excluded because whole Misgav-Ladach technique compared with Pfannenstiel technique.A prospective randomised trial.Participants: 104 women undergoing caesarean section.Interventions:1. 49 women in experimental group, Misgav-Ladach technique with non-closure of both peritoneal surfaces.2. 55 women in Pfannenstiel group with closure of both peritoneal surfaces-control.Outcomes: duration of surgery, duration of time between incision - birth, blood loss rate, postoperative pain, the delay before flatus passed, number of days with postoperative fever and duration of hospitalisation. |
| Ghezzi 2001 | Excluded because whole Joel-Cohen technique compared with Pfannenstiel technique.A prospective randomised trial.Participants: 310 women undergoing caesarean section.Interventions:1. Experimental 152 Joel-Cohen with non-closure of both peritoneal surfaces.2. 158 women who had Pfannenstiel technique with both peritoneal surfaces closed.Outcomes: operative time, opening time, laparotomy wound length, intraoperative complications and postoperative morbidity. |
| Hagen 1999 | Excluded because several techniques were compared, not only peritoneal non-closure. Women were "randomly allocated". Participants: 98 women to undergo caesarean section.Interventions:1. Experimental (48) Misgav-Ladach, non-closure of both visceral and parietal peritoneum.2. Control (50) Pfannenstiel method, women had both peritoneal surfaces closed.Outcomes: time from skin incision to delivery, duration of operation, analgesics required, wound healing problems, bowel and bladder function, urinary tract infection and length of hospital stay. |
| Heimann 2000 | Excluded because it is a comparison of Misgav-Ladach versus Pfannenstiel techniques, not only peritoneal non-closure. |
| Ho 1997 | Excluded because not clear which data refer to which group, and appear to have used standard error of the mean rather than standard deviations (differences stated to be non-significant would be significant if the figures were standard deviations). Prospective randomised trial, "randomly allocated".Participants: 190 women who underwent caesarean section.Interventions:1. 96 women with non-closure of both peritoneal surfaces.2. 94 women with closure of both peritoneal surfaces.Outcomes: duration of operation, length of hospitalisation, pain visual analogue score, amount of analgesia required, fever, wound infection. |
| Hojberg 1996 | No difference in analgesic doses was found between the 2 groups. However, the study did not include numerical information hence the exclusion. Letter written in November 2006 to author for information. |
| Jacobson 1992 | This prospective study did not provide data for analysis. |
| Juszczak 2011 | This paper brings into focus the feasibility of carrying out a randomised trial in a developing country. It does not address any of the outcomes. |
| Khadem 2008 | No details of data in this poster presentation. |
| Khadem 2009 | It is a postal presentation the details of outcome data sought but in vain. However, non-closure of peritoneum conferred improved outcomes like infectious morbidity and duration of surgery. |
| Lange 1993 | Study was pseudo-randomised and data were incomplete. This study showed that uterine involution was earlier in the non-closure group. |
| Moreira 2002 | Comparison of entire Misgav-Ladach versus traditional technique, not only peritoneal non-closure. |
| Ohel 1996 | This was a well-conducted randomised controlled trial examining the use of closure or non-closure of peritoneum at caesarean section along with the use of a double or single layer uterine closure. Unfortunately, it was not possible to separate the effect of double- or single-layer uterine closure from the closure or non-closure of peritoneum on operation time and morbidity because of the methodology used. |
| Rathnamala 2000 | A well-reported trial unfortunately, the method of group selection was not stated hence the exclusion. There is an imbalance in the proportions with a vertical abdominal incision (45% in the non-closure versus 65% in the closure group). |
| Rengerink 2011 | This study compared the 2 methods of skin closure - skin staples or sutures. It also assessed the need or otherwise of subcutaneous fat layer. It did not looked at peritoneal closure. |
| Sodowski 2000 | Method of randomisation was not stated, and data were not provided in a usable format. However, the outcomes in this study followed the general trend of favouring peritoneal non-closure as regards operating time and complication rate. |
| Stark 1995 | Retrospective analysis of 2 different operating techniques by 2 groups of surgeons, using different techniques of uterine and peritoneal closure. There was significant reduction in febrile morbidity and adhesions in repeat sections when the peritoneum was not closed, without differences in haematocrit or haemoglobin changes. Although analysis of the 2 groups showed no differences in age, gestation, gravidity, parity, previous caesarean section or rupture of membranes, this was not a randomised controlled trial, and is thus excluded. The direction of effect is consistent with the included studies. |
| Svigos 1990 | Data sought but in vain. |
| Ugur 2010 | A very important long-time outcome of adhesions formation in this trial but no data were supplied for analysis. This is an abstract of a congress presentation. |
| Wallin 1999 | Excluded because peritoneal non-closure was not the only intervention studied. Allocation was by last digit of hospital number (odd or even). 72 women undergoing caesarean section through a Pfannenstiel incision.1. Experimental (36), non-closure of parietal and visceral peritoneum.2. Control (36), both visceral and parietal peritoneum were sutured. Postoperative morbidity, days in hospital. |
| Woyton 2000 | Participants were divided into 2 groups without randomisation (307 no closure of visceral peritoneum, 270 closure). It is noteworthy that non-closure of peritoneum was associated with less bladder peritoneal adhesions. |
| Xavier 1999 | Excluded because whole Joel-Cohen technique used.Randomised trial with pre-allocation concealment.Participants: 46 women undergoing caesarean section.Interventions:1. 23 women in the experimental Joel Cohen group including non-closure of both peritoneal surfaces.2. 23 women in the control group with Pfannenstiel technique, where both surfaces were closed.Outcomes: duration of operation, analgesic dosages, bowel emptying, postoperative fever and antibiotics, scar complications. |
Mocanasu 2005
| Methods | Randomised trial. |
| Participants | 80 pregnant women undergoing caesarean section. |
| Interventions | Closure of peritoneum versus non-closure. |
| Outcomes | Short-term outcomes. |
| Notes | Awaiting full data from Romanian translator. |
Nokiani 2010
| Trial name or title | |
| Methods | Randomised trial. |
| Participants | Women for caesarean section. |
| Interventions | Peritoneum repaired versus not repaired. |
| Outcomes | Postoperative pain, ileus, analgesic requirement. |
| Starting date | 2010. |
| Contact information | |
| Notes | May be published in Arabic. |
Non-closure of both parietal and visceral peritoneum versus closure of both peritoneal layers
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Postoperative adhesions | 4 | 282 | Risk Ratio (M-H, Fixed, 95% CI) | 0.99 [0.76, 1.29] |
| 2 Wound infection | 13 | 15430 | Risk Ratio (M-H, Fixed, 95% CI) | 0.96 [0.86, 1.07] |
| 3 Uterine dehiscence | 1 | 100 | Risk Ratio (M-H, Fixed, 95% CI) | 0.14 [0.01, 2.70] |
| 4 Numbers of narcotic analgesics required | 7 | 1657 | Mean Difference (IV, Random, 95% CI) | -0.18 [-0.39, 0.02] |
| 5 Additional analgesia after 24-48 hours | 1 | 9675 | Risk Ratio (M-H, Fixed, 95% CI) | 0.94 [0.79, 1.12] |
| 6 Infectious morbidity | 11 | 14985 | Risk Ratio (M-H, Random, 95% CI) | 0.92 [0.72, 1.16] |
| 7 Endometritis | 5 | 10538 | Risk Ratio (M-H, Fixed, 95% CI) | 1.07 [0.78, 1.46] |
| 8 Operating time (minutes) | 16 | 15480 | Mean Difference (IV, Random, 95% CI) | -5.81 [-7.68, -3.93] |
| 9 Postoperative days in hospital | 13 | 14906 | Mean Difference (IV, Random, 95% CI) | -0.26 [-0.47, -0.05] |
| 10 Chronic pelvic pain | 1 | 112 | Risk Ratio (M-H, Fixed, 95% CI) | 0.49 [0.25, 0.98] |
| 11 Pain at 6 weeks postpartum | 1 | 9465 | Risk Ratio (M-H, Fixed, 95% CI) | 1.04 [0.80, 1.36] |
| 12 Secondary infertility | 1 | 144 | Risk Ratio (M-H, Fixed, 95% CI) | 0.89 [0.23, 3.44] |
| 13 Blood transfusion > 1 unit (not prespecified outcome) | 1 | 9675 | Risk Ratio (M-H, Fixed, 95% CI) | 0.98 [0.69, 1.39] |
| 14 Maternal death (not prespecified outcome) | 1 | 9675 | Risk Ratio (M-H, Fixed, 95% CI) | 1.49 [0.25, 8.92] |
| 15 Intervention for postpartum haemorrhage (not prespecified outcome) | 1 | 9675 | Risk Ratio (M-H, Fixed, 95% CI) | 0.99 [0.72, 1.38] |
| 16 Readmission to hospital within 6 weeks (not prespecified outcome) | 1 | 9465 | Risk Ratio (M-H, Fixed, 95% CI) | 1.00 [0.67, 1.49] |
Non-closure of visceral peritoneum only versus closure of both peritoneal layers
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Adhesion formation | 2 | 157 | Risk Ratio (M-H, Fixed, 95% CI) | 2.49 [1.49, 4.16] |
| 2 Wound infection | 2 | 789 | Risk Ratio (M-H, Fixed, 95% CI) | 0.36 [0.14, 0.89] |
| 3 Postoperative fever | 3 | 889 | Risk Ratio (M-H, Random, 95% CI) | 0.60 [0.29, 1.27] |
| 4 Endometritis | 1 | 240 | Risk Ratio (M-H, Fixed, 95% CI) | 3.0 [0.12, 72.91] |
| 5 Operating time (minutes) | 1 | 544 | Mean Difference (IV, Fixed, 95% CI) | -6.30 [-9.22, -3.38] |
| 6 Postoperative days in hospital | 1 | 549 | Mean Difference (IV, Fixed, 95% CI) | -0.70 [-0.98, -0.42] |
Non-closure of parietal peritoneum only versus closure of both peritoneal layers
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Wound infection | 1 | 248 | Risk Ratio (M-H, Fixed, 95% CI) | 0.95 [0.14, 6.66] |
| 2 Postoperative pain | 1 | 325 | Risk Ratio (M-H, Fixed, 95% CI) | 0.45 [0.31, 0.66] |
| 3 Postoperative fever | 1 | 40 | Risk Ratio (M-H, Fixed, 95% CI) | 0.18 [0.01, 3.56] |
| 4 Endometritis | 1 | 248 | Risk Ratio (M-H, Fixed, 95% CI) | 0.88 [0.53, 1.46] |
| 5 Operating time (minutes) | 1 | 248 | Mean Difference (IV, Fixed, 95% CI) | -5.10 [-8.71, -1.49] |
| 6 Postoperative days in hospital | 2 | 288 | Mean Difference (IV, Random, 95% CI) | -0.15 [-1.20, 0.91] |
| 7 Mobilisation time in hours (not prespecified outcome) | 1 | 110 | Mean Difference (IV, Fixed, 95% CI) | -1.89 [-3.18, -0.60] |
| 8 Time to oral intake in hours (not prespecified outcome) | 1 | 110 | Mean Difference (IV, Fixed, 95% CI) | -2.31 [-3.76, -0.86] |
| 9 Drop in haemoglobin g/dL (not prespecified outcome) | 1 | 110 | Mean Difference (IV, Fixed, 95% CI) | 0.28 [-0.03, 0.59] |
| 10 Blood loss (not prespecified outcome) | 1 | 110 | Mean Difference (IV, Fixed, 95% CI) | 56.97 [-28.08, 142.02] |
| 11 Time to flatus (not prespecified outcome) | 1 | 110 | Mean Difference (IV, Fixed, 95% CI) | -0.04 [-1.99, 1.91] |
| 12 Wound pain, day 1 (visual analogue score) | 1 | 325 | Mean Difference (IV, Fixed, 95% CI) | -1.60 [-1.97, -1.23] |
| 13 Persistent abdominal pain after 8 months (numerical rating scale) | 1 | 325 | Mean Difference (IV, Fixed, 95% CI) | -1.10 [-1.39, -0.81] |
Non closure versus closure of visceral peritoneum when parietal peritoneum is closed
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | techniques |
| 1 Urinary frequency at 8 weeks | 1 | 582 | Risk Ratio (M-H, Fixed, 95% CI) | 0.24 [0.13, 0.45] |
| 2 Urgency of urination | 1 | 582 | Risk Ratio (M-H, Fixed, 95% CI) | 0.30 [0.18, 0.51] |
| 3 Stress incontinence | 1 | 582 | Risk Ratio (M-H, Fixed, 95% CI) | 0.45 [0.21, 0.96] |