Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial

Abstract

SummaryBackgroundThe CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up.MethodsThe CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967.FindingsBetween Sept 1, 2011, and Sept 30, 2014, 13 153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39–1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83–1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71–1·18) or of ectopic pregnancy (0·50, 0·15–1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46–1·32) or a composite of pregnancy complications (1·20, 0·75–1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61–1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32–29·29). Overall, severe adverse outcomes were uncommon in these settings.InterpretationAlthough our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches.FundingUK Medical Research Council and the Department for International Development.

Uterine Scar Healing After Cesarean Section: Managing an Old Surgery in an Evidence-Based Environment

“…6 In this study, authors considered all women with a complete uterine rupture as cases (n = 175), and all women with two births with TOLAC at term and no uterine rupture as controls (n = 272). Confirming what was previously reported in the CORONIS trial, 4 there was no association between single-layer closure and uterine rupture at term.…”

“…A few years later, the publication of the CORONIS randomized controlled trial's results at 3 years followup contributed to a paradigm shift in clinical practice. 4 In this large study, the authors investigated the rates of pelvic pain, deep dyspareunia, hysterectomy, and outcomes of subsequent pregnancies in women undergoing cesarean section following blunt versus sharp abdominal entry, exteriorization of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus nonclosure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Interestingly and unexpectedly, there was no evidence of a difference in risk of abdominal hernias for blunt versus sharp abdominal entry, no evidence of a difference in risk of infertility or of ectopic pregnancy for exteriorization of the uterus versus intra-abdominal repair, no evidence of a difference in maternal death or a composite of pregnancy complications for single-versus doublelayer closure of the uterus, no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility for closure versus nonclosure of the peritoneum and, finally, no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy for chromic catgut versus polyglactin-910 sutures.…”

The Case for Standardizing Cesarean Delivery Technique

“…The authors suggest that in the absence of clinical benefit, considerations such as cost and time savings should dictate appropriate technique. 15 We concur wholeheartedly with this logic. Omitting steps with no benefit are just as important as including those with benefit and critical to establishing a standardized technique.…”

“…Since the previous systematic review by Dahlke et al in 2013, the CORONIS trial has reported short-term and long-term data for more than 15,000 women undergoing cesarean delivery randomized to three of five alternative surgical techniques. 4 , 13 – 15 There was no difference in outcomes related to cesarean delivery surgical technique including long-term outcomes such as subsequent uterine rupture (indicating that double layer uterine closure is not protective) or symptoms attributable to intra-abdominal adhesions (indicating that peritoneal closure is not protective). The authors suggest that in the absence of clinical benefit, considerations such as cost and time savings should dictate appropriate technique.…”

The peritoneum at laparotomy: A survey of gynaecological practice among Nigerian gynaecologists

“…[9] A collaborative study published in 2016, CORONIS, observed ~8 100 women during a 3-year follow-up and did not find any difference in the occurrence of pelvic pain, dyspareunia, bowel obstruction, bladder surgery, infertility and ectopic pregnancy, whether the peritoneum was closed with sutures or not. [11] Perhaps a longer follow-up of the CORONIS study in future might give clinicians the final answer to the fate of the peritoneum. A paradigm shift in practice cannot be succinctly advocated until the possible chronic sequelae have been assessed in studies incorporating longer follow-up periods.…”