Materials and Methods

The study was a randomized controlled trial comparing the effect of closure with nonclosure of the visceral and parietal peritoneum on adhesion formation, as assessed at a subsequent cesarean section. The study, conducted at Barzilai Medical Center, Ashkelon, Israel, was approved by the Ethics and Research Committee, and written informed consent was obtained from all recruited women. Prior to this study, our standard technique did not include peritoneal closure. Of the 1150 women undergoing primary cesarean section from May 2004 through May 2007, 533 consented to participate and were randomly allocated to closure or nonclosure ( Figure ). Reasons for exclusions were lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent, previous pelvic or abdominal surgery, or chorioamnionitis. The randomization sequence was computer generated, instructing the surgeon to leave the peritoneum open or to close it.

Study enrollment randomization and assessment

Kapustian. Peritoneal closure at cesarean and adhesions. Am J Obstet Gynecol 2012.

Standard technique was performed in all operations. The type of anesthesia was chosen by the anesthesiologist without reference to the treatment group. Surgeries were performed by an attending physician with a resident, who were aware of the nature of the study. All surgeons were instructed to follow a standardized technique. The abdomen was opened by a Pfannenstiel incision. A transverse lower segment uterine incision was closed with 2 layers of continuous 1 polyglactin suture. In the study group both the visceral and parietal peritoneum were closed using a continuous absorbable suture (polyglactin 2-0), while in the nonclosure group both layers remained unsutured. Rectus muscles were not closed. The use of interrupted subcutaneous absorbable sutures (polyglactin 2-0) was left to the discretion of the surgeon. The skin was approximated using staples. All patients received intraoperative prophylactic intravenous cefazolin (1 g).

Women subsequently returning for a repeat cesarean (elective or emergency) were evaluated intraoperatively for the presence of adhesions by the attending surgeon. Accrual continued until May 2010, when the predefined sample size was reached. The surgeon was not knowledgeable (blinded) as to the patient allocation. The presence of adhesions was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between the bladder and the uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A score sheet was used. A point of 0 was given if no adhesions were present. Adhesions at any site were given 1 point (mild adhesions) if they could be separated bluntly and 2 points (severe adhesions) if sharp dissection (scissors) was employed. If a single adhesion had both a mild and severe component, it was regarded as severe. An arithmetic sum of all points at all sites was named the “adhesion score.” Time from skin incision delivery was noted. The uterus was routinely lifted through the abdominal wall incision to facilitate its suture, and if this was not feasible, due to adhesions, it was recorded. The 2 study arms were compared with regard to the presence of adhesions at each site, the mean sum of the adhesion score, the presence of difficulty in extraction of the uterus, and time from incision to delivery.

Sample size was calculated based on the primary outcome measure that was the presence of adhesions. Assuming an adhesion rate of 60% in the nonclosure group, sample size was calculated for a 50% reduction of the adhesion rate, with an alpha of 0.05 and a power of 80. Given this calculation, the minimum size was 42 cases in each group. For statistical analysis Student t test, Mann-Whitney U , Pearson χ ² , or Fisher exact test was used, as appropriate; P < .05 was considered significant.

This study is registered on ClinicalTrials.gov ( NCT01183000 ).