OBJECTIVE: To compare extra-abdominal to intra-abdominal repair of the uterine incision at cesarean delivery. METHODS: This is a randomized controlled trial conducted at the Instituto Materno-Infantil Prof. Fernando Figueira (Recife, Brazil). Inclusion criteria were indication for cesarean delivery and gestational age of 24 weeks or more. Patients with two or more cesarean deliveries, chorioamnionitis, hemorrhage, inability to consent, and previous abdominal surgery were excluded. Variables analyzed were nausea, vomiting, mean operative time, intraoperative blood loss, number of surgical sutures for uterine repair, postoperative pain evaluated by the visual analog scale, number of postoperative analgesic doses, surgical site infection, and endometritis. RESULTS: The analysis included 325 patients randomized forexteriorized uterine repairand 312 patients randomized for in situ uterine repair. A significant difference was observed in duration of surgery: lasting less than 45 minutes (44% with exteriorized uterus compared with 35.3% with in situ uterus, P=.02; number needed to treat=12) and less need of sutures (18.2% requiring one suture in the exteriorized group compared with 11.9% in the in situ group, P=.03; number needed to treat=16). The frequency of moderate or severe pain 6 hours after surgery was low [corrected] in women with in situ [corrected] repair (23.1%) when compared to those with the uterus exteriorized [corrected] (32.6%) (P=.026; number needed to treat=11). There was no difference between the groups in relation to other variables. CONCLUSION: There is no significant difference between extra-abdominal and intra-abdominal repair of the uterine incision at cesarean delivery, but the number of sutures is lower and surgical time is shorter with extra-abdominal repair, although moderate and severe pain at 6 hours is less frequent with in situ uterine repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00550888.
RCT Entities:
OBJECTIVE: To compare extra-abdominal to intra-abdominal repair of the uterine incision at cesarean delivery. METHODS: This is a randomized controlled trial conducted at the Instituto Materno-Infantil Prof. Fernando Figueira (Recife, Brazil). Inclusion criteria were indication for cesarean delivery and gestational age of 24 weeks or more. Patients with two or more cesarean deliveries, chorioamnionitis, hemorrhage, inability to consent, and previous abdominal surgery were excluded. Variables analyzed were nausea, vomiting, mean operative time, intraoperative blood loss, number of surgical sutures for uterine repair, postoperative pain evaluated by the visual analog scale, number of postoperative analgesic doses, surgical site infection, and endometritis. RESULTS: The analysis included 325 patients randomized for exteriorized uterine repair and 312 patients randomized for in situ uterine repair. A significant difference was observed in duration of surgery: lasting less than 45 minutes (44% with exteriorized uterus compared with 35.3% with in situ uterus, P=.02; number needed to treat=12) and less need of sutures (18.2% requiring one suture in the exteriorized group compared with 11.9% in the in situ group, P=.03; number needed to treat=16). The frequency of moderate or severe pain 6 hours after surgery was low [corrected] in women with in situ [corrected] repair (23.1%) when compared to those with the uterus exteriorized [corrected] (32.6%) (P=.026; number needed to treat=11). There was no difference between the groups in relation to other variables. CONCLUSION: There is no significant difference between extra-abdominal and intra-abdominal repair of the uterine incision at cesarean delivery, but the number of sutures is lower and surgical time is shorter with extra-abdominal repair, although moderate and severe pain at 6 hours is less frequent with in situ uterine repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00550888.
Authors: David Moher; Sally Hopewell; Kenneth F Schulz; Victor Montori; Peter C Gøtzsche; P J Devereaux; Diana Elbourne; Matthias Egger; Douglas G Altman Journal: BMJ Date: 2010-03-23