CORONIS Trial - a fractional factorial unmasked randomised controlled trial of caesarean section surgical techniques in developing countries
Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years - about 20-25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. This large fractional, factorial randomised controlled trial will recruit 15,000 women and will evaluate five elements of the caesarean section operation: (1) Blunt versus sharp abdominal entry; (2) exteriorisation of the uterus for repair versus intra-abdominal repair; (3) single versus double layer closure of the uterus; (4) closure versus non-closure of the peritoneum (pelvic and parietal); (5) Chromic catgut versus Polyglactin-910 for uterine repair. The trial started recruiting on 20 May 2007 and closed recruitment 31st December 2010. The main trial results were published in the Lancet in July 2013.
- Brocklehurst P, on behalf of the CORONIS Trial Collaborative Group. The CORONIS Trial: International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy Childbirth. 2007;7:24.
- The CORONIS Collaborative Group, Ablos E, Addo V, Brocklehurst P, El Sheikh M, Farrell B, Gray S, Hardy P, Juszczak E, Mathews JE, Masood SN, Oyarzun E, Oyieke J, Sharma JB, Spark P. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. The Lancet. 2013;382(9888):234-48.
- Group CC, Abalos E, Oyarzun E, Addo V, Sharma JB, Matthews J, Oyieke J, Masood SN, El Sheikh MA, Brocklehurst P, Farrell B, Gray S, Hardy P, Jamieson N, Juszczak E, Spark P. CORONIS - International study of caesarean section surgical techniques: the follow-up study. BMC Pregnancy Childbirth. 2013;13:215.
- Coronis Collaborative Group. Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial. Lancet. 2016;388(10039):62-72.