Laparoscopic sacrocolpopexy using barbed sutures for mesh fixation and peritoneal closure: A safe option to reduce operational times.

INTRODUCTION: Laparoscopic sacrocolpopexy (LSC) has established itself as a safe method for the management of pelvic organ prolapse (POP). Laparoscopic suturing is a time-consuming intraoperative task during LSC. Self-retaining barbed sutures (SBSs) are known to reduce the operative time in laparoscopic cases. The current study aimed to evaluate the efficacy and safety of SBS during the performance of LSC.
MATERIALS AND METHODS: Twenty female patients with symptomatic POP were treated with LSC by an expert surgeon. The preoperative evaluation included the International Continence Society POP-quantification (POP-Q) and the prolapse-specific quality-of-life questionnaire Mesh fixation was performed with SBS anteriorly on the anterior vaginal wall and posteriorly on the levator ani muscle. A 5-mm titanium tacking device was used for promontofixation. The peritoneum was also closed with an SBS.
RESULTS: Mean patient's age was 63 years (range: 50-79 years). According to POP-Q, system 3 patients (15%) had Stage I, 12 patients (60%) had Stage II, 3 patients (15%) had Stage III, and 2 patients (10%) had Stage IV prolapse. Concomitant hysterectomy was performed in 14 patients, respectively. Mean operative time was 99.75 (range: 65-140) min, mean blood loss was 57.75 (range: 30-120) ml. One patient had a bladder perforation intraoperatively, and three patients developed transient fever postoperatively. One patient had a recurrent cystocele and three patients recurrent rectocele.
CONCLUSIONS: The current study renders the use of SBS during LSC to be safe and efficient. Further comparative studies would elucidate the impact of the use of SBS in LSC.

INTRODUCTION

Pelvic organ prolapse (POP) is a serious burden that significantly diminishes the quality-of-life of the female patients and its treatment is associated with a high cost.[1] The incidence of POP shows an increasing trend.[2] Women in the United States have 11% lifetime risk of being diagnosed with POP or urinary incontinence, and around 200.000 surgical procedures are being performed for the treatment of POP annually.[3] Among several surgical techniques that are available for the treatment of POP, open abdominal sacrocolpopexy (ASC) has been documented as the gold standard surgical treatment. The latter approach is associated with lower recurrence rates and superior outcomes when compared to the transvaginal approach.[4]

Laparoscopic sacrocolpopexy (LSC) has established itself as a safe method for treatment of POP in specialized laparoscopy centers. Urogynecologists worldwide have demonstrated excellent short- and long-term functional and anatomical outcomes.[5] This minimal invasive technique delivers lower morbidity rates and decreased blood loss when compared to conventional ASC.[6] The learning curve lies between 15 and 24 cases, and approximately 40 cases are required to master this laparoscopic technique.[78] During laparoscopy, suturing and knot tying are challenging and time-consuming skills related to steep learning curves.[9] Self-retaining barbed sutures (SBSs) have previously been used in other open and laparoscopic operations with safety and efficacy. SBSs are known to reduce operation time, especially during laparoscopy by eliminating the need for knot tying.[101112] With the current study, we aim to evaluate the efficacy and safety of SBSs during LSC, describe in detail the technique, and present our follow-up data.

MATERIALS AND METHODS

Study population

Twenty consecutive female patients with symptomatic POP were treated by an expert laparoscopic surgeon with LSC.

Indications

The indications for LSC were primary or recurrent POP including deficiency of the posterior (rectocele), middle (vaginal vault prolapse, enterocele), and anterior compartment (cystocele) or combination of them. Symptoms related to the POP were also evaluated for the decision to propose surgery.

Preoperative evaluation

Patient demographics, clinical characteristics including history taking, physical examination, urogenital ultrasound, Pap smear, and urine examinations were recorded. Multichannel urodynamic examinations with and without reduction of the prolapse were performed on patients before surgery. An 1 h weighting pad test took place in all cases that incontinence was diagnosed. Continence was defined as <2 g of urine. Mild to moderate stress incontinence was defined between 2 and 20 g, severe incontinence between 10 and 50 g, and very severe incontinence over 50 g, respectively.[13] International Continence Society POP-quantification (POP-Q) system was used to evaluate the degree of prolapse with the patient in dorsal lithotomy position.[14] The quality-of-life related parameters were evaluated with the use prolapse-specific quality-of-life questionnaire (P-QOL).[15]

Surgical technique

The patient was placed in 20°–25° Trendelenburg position with the hands parallel to the body after the introduction of general anesthesia. The abdomen and the vagina were meticulously scrubbed. A Foley catheter was inserted in the bladder. The sites of trocar placement were identical to the previously described extraperitoneal endoscopic radical prostatectomy technique.[16] Nevertheless, the access was transperitoneal and not extraperitoneal as the latter procedure is performed. In short, the camera trocar was placed according to the Hasson technique through a medial infraumbilical incision. Four other trocars were placed under direct visual control; a 12-mm trocar in the left iliac fossa 3 cm medially to the to the anterior superior iliac spine, a 5-mm trocar in the right iliac fossa at a mirror position to the previous trocar, a 5-mm trocar on the hypothetical line between the umbilicus, and the right iliac spine approximately at lateral margin of the rectus abdominis. Another 5-mm trocar was placed 3 cm caudally to the crossing of the aforementioned hypothetical line with the left lateral margin of the rectus abdominis.

The peritoneum was incised parallel to the right side of sigmoid colon, starting approximately 2 cm above the level of sacral promontory, and extending toward the recto-uterine pouch [Figure 1a]. The right ureter was always recognized to prevent its injury. A malleable retractor was placed into the vagina for the manipulation of the vagina and uterus. This maneuver allows the maximal exposure of these structures for the subtotal hysterectomy with bilateral oophorectomy and preservation of the cervix, which took place in the cases that the uterus was present [Figure 1b]. For the above steps of the procedure, the peritoneum overlying the uterus (or vagina) was incised, and the incision was extended anteriorly to the lower third of the vagina [Figure 2a] and posteriorly to the levator ani muscle [Figure 2b]. The uterus and the adnexes were inserted in an endoscopic bag and were placed on the left side on the abdomen over the level of the iliac vessels. Then, the incision of the peritoneum facing the sacral and the incision of the rectovaginal pouch was joined by extending both incisions. A custom-made soft y-shaped polypropylene mesh was prepared. The bifurcated side of the mesh was placed anteriorly in the vesicovaginal space and posteriorly in the prerectal space to the level of the levator ani muscles. Mesh fixation was carried out with SBSs (3-0 V-Loc™ 180 wound closure device, Covidien, Mansfield, USA), starting with the fixation of the posterior portion of the mesh on the posterior of the vaginal wall at the level of levator ani muscle [Figure 3a] and continued with the fixation of anterior portion of the mesh on the anterior vaginal wall [Figure 3b]. The nonbifurcated end of the mesh was then passed toward the sacral promontory [Figure 4a] and fixed on it with a 5 mm titanium tack device (ProTack, Covidien, Mansfield, USA) [Figure 4b]. To prevent erosion of the surrounding tissues by the mesh, the previously opened peritoneum was closed over the mesh [Figure 5a]. The closure was also carried out with the SBS [Figure 5b]. A drain was placed through the lateral right 5 mm trocar, and all trocars were removed under direct vision. It should be noted that patients with very severe incontinence as defined by the pad-weighing test underwent an additional mid-urethral sling procedure.

Figure 1

(a) Peritoneal incision. (b) Peritoneal exposure

Figure 2

(a) Exposure of anterior vaginal wall. (b) Exposure of posterior vaginal wall

Figure 3

(a) Spreading of mesh in the posterior vaginal wall (b) Fixation of mesh on the posterior vaginal wall

Figure 4

(a) Fixation of mesh over anterior vaginal wall. (b) Fixation of proximal part of mesh over sacral promontory

Figure 5

(a) Closure of peritoneum over the mesh. (b) Final appearance of posterior peritoneum after closure

Postoperative management and follow-up

The drain and the Foley catheter were routinely removed on the 1st postoperative day, and the patient was discharged on the 2nd postoperative day. Intravenous nonopioid analgesics were administered for pain management. Prophylaxis for deep vein thrombosis was administered during the hospitalization (low-molecular-weight heparin). The follow-up of the patients included appointments at 1st and 12th months postoperatively. Evaluation of symptomatology, abdominal and vaginal examination took place at these appointments. Pad-weighting test was also repeated. Anatomical recurrence was defined as the absence of Grade II prolapse at any anatomic site (POPQ Grade ≥II).[17] The quality-of-life of the patients was also accessed according to the P-QOL. In the 2nd year, patients were examined and reevaluated at the urology office on a need basis rather than scheduled appointments.

Data recording and analysis

Recording of the data of the current study took place in a prospective database, which was approved by the Institutional Scientific Board. All patients gave their informed consent. Complications were classified according to the Clavien-Dindo classification.[18] Descriptive univariate statistics was utilized using the IBM SPSS version 20 (IBM Corp., Armonk, NY, USA).

RESULTS

Mean patient age was 63 (range: 50–79) years. Patient demographics and preoperative evaluation of the patients are presented in Table 1. The majority of patients had Grade II prolapse. Lower urinary tract symptoms were reported by 8 patients while incontinence was noted in 17 patients.

Table 1

Summary of patient demographics and preoperative evaluation

Mean operative time was 99.75 (range: 65–140) min. Total and subtotal hysterectomy was concomitantly performed in 4 and 10 patients, respectively. In four patients with very severe stress incontinence, a mid-urethral sling was placed. The aforementioned operative time included the time for any concomitant procedure. Major bleeding was not observed during the procedures of the current series. Mean blood loss for all cases was 57.75 (range: 30–120) ml. Intraoperative complications included one patient having a minor bladder injury which was managed by suturing. Three patients had transient fever episodes postoperatively which resolved with conservative treatment. Mean hospitalization was 1.65 (1–3) days. The perioperative data of the current series are summarized in Table 2. The mean postoperative follow-up duration was 13.6 months (3–30 months). No complications were reported during this period. One patient had 3 months, and two patients had 6 months of follow-up. The remaining of the patients exceeded the 12 months.

Table 2

Summary of the perioperative data

Anatomical outcome

The restoration of the anatomy showed that there was a significant improvement in the measurements of POP-Q between the preoperative and the postoperative values regardless of the follow-up appointment (P < 0.001). The values recorded among the follow-up appointments were similar. Table 3 summarizes the POP-Q results. Cystocele recurred in one patient and rectocele recurred in 3 patients. Altogether, no recurrence was observed in 80% of the patients.

Table 3

Comparison of the preoperative and postoperative measurement values of pelvic organ prolapse-quantification

Functional outcome

Incontinence was resolved in 13 out of 14 patients with stress incontinence. One patient with Grade IV prolapse and stress incontinence showed mild to moderate stress incontinence during the follow-up period. In three patients who were diagnosed to have mixed incontinence before surgery, no incontinence was observed postoperatively. However, two of these three patients required treatment with anticholinergics to suppress urgency symptoms. LSC resolved the symptoms in two of four patients complaining preoperatively for constipation. The quality-of-life was significantly improved after the LSC. There was significant improvement between the preoperative and postoperative P-QOL scores. The improvement was noted soon after the first of follow-up and continued throughout the follow-up period. A summary of the P-QOL results is described in Table 4.

Table 4

Comparison of the preoperative to postoperative prolapse quality-of-life domain scores

DISCUSSION

LSC represents an alternative to open sacrocolpopexy. Sergent et al.[19] performed LSC on 119 patients in a similar fashion to our technique. They placed a posterior reversed Y-shaped prosthesis to the right and left levator ani muscles anteriorly and then to the posterior vaginal wall. An anterior prosthetic tape was placed underneath the bladder and attached to the vagina and the uterine cervix. Mean operative time was 185 ± 24 min. Conversion to ASC was necessary in 5 patients (4%). Mean follow-up was 34.2 ± 20.5 months. Their objective evaluation showed satisfactory results in 103 (89%) patients. Mesh erosion was observed in 5 (4%) patients. Bladder injury and bowel injury were observed in 3 (2.6%) and 2 (1.7%) patients, respectively. In their systematic review on LSC and robotic-assisted LSC, Lee et al.[6] screened 378 articles which were published between 1996 and 2013. 11 series of LSC including a total of 1221 patients were considered in their evaluation. The objective success of the LSC ranged between 78 and 100%. The conversion rate to ASC was 0%–11%. Mean operative time was calculated to be 124 (range: 55–185) min. In the current study, shorter operative times were recorded. Laparoscopic suturing and knot tying are challenging and time-consuming skills. Even though our patients were operated by an experienced laparoscopic surgeon, the use of SBSs probably contributed to the shorter mean operative times in comparison to the literature.

The use of SBSs may also facilitate the LSC learning curve of novice surgeons. Current literature suggests that approximately 18–40 cases are necessary to overcome the learning curve of LSC.[78] Mustafa et al.[8] retrospectively reviewed 47 consecutive women undergoing LSC and reported a significant drop in mean operative time from 196 to 162 min between the first 15 and the last 30 cases. Nevertheless, blood loss and complication rates did not change between the two groups. A similar decrease in operative time was also observed by Claerhout et al. after 18–24 cases.[7] The current series could not provide any evidence regarding the learning curve as the surgeon was already over their learning curve with LSC by having performed more than 50 LSCs before initiating the use of SBS.

The estimated blood loss of approximately 60 ml was lower than the majority of the series in literature.[6] The conversion rate in literature ranges between 0% and 25%.[619] In the current series, there was no need for conversion to open surgery.

Claerhout et al. followed a series of 132 women with vaginal vault prolapse undergoing LSC up to 12.5 months.[7] The investigators achieved anatomic correction rate of 98% for the apical compartment, and similarly to our patient cohort, the majority of anatomic failures were at the posterior compartment. Patient satisfaction was 91.7%, and patients reported improved quality-of-life. Similarly, a recent systematic review proposed objective success rates of 83%–100%.[6] The anatomical and quality-of-life outcome were also directly comparable to the results presented in literature.[719202122] The recurrence rate based on the criteria of the study was 20%. Nevertheless, the patient satisfaction as depicted through the P-QOL scores remained high throughout the follow-up period. The correction of the anatomy may not be optimal but results in relief of the symptoms. It is not uncommon to examine patients with POP without significant symptomatology[2324] and even a “failed” reconstruction according to the defined criteria may benefit the symptomatology of the patient. Most of the patient series in the aforementioned systematic review did not use a standardized reporting system for complications. However, minimal complication rates were observed. 1221 patients showed 1% (4 patients) mesh erosion, 1% (5 patients) bladder injury, 0.3% (1 patient) bowel injury, 3% (9 patients) de novo stress urinary incontinence, 4% (13 patients) lower urinary track symptoms, and 1% (2 patients) dyspareunia. In the current study, bladder perforation took place in 1 case (5%). Mesh erosion is reported in 0%–9% of the LSC cases.[6] In the current series, mesh erosion was not observed. The use of SBSs did not seem to increase intraoperative organ injury or mesh erosion rates and showed similar postoperative complication rates and success rates when compared to conventional LSC.

In the series by Claerhout et al., de novo constipation and de novo dyspareunia developed in 5% and 19% of the patients.[7] Similarly, Lee et al. reported constipation in 0%–19% of the cases.[6] In the current population, bowel-related symptoms such as constipation were reduced after the procedure with 20% of the patients suffering preoperatively and 10% of them postoperatively. Other bowel-related problems, such as ileus, small bowel obstruction, rectal discomfort, or fecal incontinence were not noted. The low rate of the above issues should probably be attributed to the retroperitonealization of the mesh which is considered as a way to avoid bowel-related complications in the literature[6] and was routinely done in the current series with the suturing of the peritoneum over the mesh with SBS. Dyspareunia was not observed in the current series and is reported in 0%–2% of the cases in contemporary literature.[6] Sexually active patients reported improved sexual activity in their postoperative P-QOL assessments.

The use of SBS has been proposed by other investigators with favorable results. Borahay et al. performed robotic-assisted sacrocolpopexy to twenty patients and concluded to the safety and efficacy of these sutures at least during the 1st year after the procedure.[25] The investigators had a mean follow-up period of 17 months and they observed very limited incidence of mesh or suture erosion. Nevertheless, the use of the SBS requires further investigation with follow-up periods overcoming the 1 year.

A limitation of the current investigation is the lack of a comparative group with standard LSC (without the use of SBS). The use of retrospective data on standard LSC would reduce the quality-of-the study, and the authors favored the presentation of high-quality, objective evaluation data. The relative small cohort of patients sets the background for additional investigation on the use of SBS in LSC. The involvement of expert surgeons with a large laparoscopic expertise is another limitation as the currently presented results, especially in terms of operative time and complications may not be reproducible by less experienced surgeons.

CONCLUSIONS

Our initial experience renders the use of SBSs during LSC to be safe and efficient in experienced hands. Improvement in the operative time was observed with the presented technique in comparison to the current literature. Further prospective studies are deemed necessary to affirm its safety, efficacy, and the contribution of SBS in facilitating the learning curve of LSC.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.