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|Title: ||Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial|
|Authors: ||Konney, Thomas Okpoti|
|Issue Date: ||4-May-2016|
|Abstract: ||Background The 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.
Methods The 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 fi rst 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 nonclosure 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.
Findings Between 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 diff erence 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 diff erence 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.
Interpretation Although 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.|
|Appears in Collections:||College of Health Sciences|
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