All caesarean section surgical techniques yield the same results: CORONIS Trial

The global C section rate is currently varying between 6% to 27% with an average of 19% of all births worldwide. In some countries the rate has reached all time high of 50% specially in Brazil, Iran, and Mexico, resulting in millions of women undergoing unnecessary surgery.

International health care community opines that a C-section rate of 10-15% is optimal, at which maternal and neonatal mortality is at its lowest, but anything in excess does not improve the statistics further.

Amazingly, no standard evidence based guidelines exist or best practice have been developed for this most commonly performed reproductive-age women surgery worldwide. The different in surgical techniques includes blunt versus sharp abdominal entry, single versus double layer closure, closure versus non-closure of the peritoneum, and polyglactin sutures over chromic catgut.

That’s what makes the results of CORONIS trail published in May, 2016 issue of The Lancet so important for healthcare providers all over the world. The trial was designed to assess whether any particular surgical technique was associated with better maternal and fetal outcome.

The CORONIS trial is a pragmatic international non-regular fractional, factorial, unmasked, randomized controlled trial (RCT)conducted at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. The study subjects consisted of women who were primi parous or with previous section planned to undergo C-section by transverse abdominal incision.

Women were randomly allotted to undergo one intervention from the each of the 5 assigned pairs of surgical techniques:

1. blunt versus sharp abdominal entry,
2. exteriorization 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,
5. and chromic catgut versus polyglactin-910 for uterine repair.

The short term outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit.

The long term outcome included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies.  13,153 (84%) of 15, 633 women were followed up for an average of 3.8 years.

No single technique was found superior to other in terms of maternal morbidity or long-term complications.  For blunt versus sharp abdominal entry, there was no evidence of a difference in the risk of abdominal hernias, for exteriorization of uterus for suturing, no difference was found in terms of increased infection, infertility or subsequent abdominal pregnancy. Increased incidence of maternal deaths, uterine rupture or dehiscence was no different when uterine incision was closed in single vs double layer.

The groups also did not show any difference in terms of uterine adhesions or pelvic adhesions when compared on closure versus non-closure of the peritoneum.

Only a slight difference was noted in terms of requiring blood transfusion in immediate post-operative period when comparing the use of polyglactin-910 vs chromic catgut. Those patients in whom chromic catgut was used required less blood transfusion but, long term follow up did not show any difference. The short term follow up results published in July, 2013 edition of The Lancet. 

The study has several limitations in terms of the participating centers being large tertiary care hospitals with highly skilled and experienced health care staff. The anticipated subsequent pregnancy rate in these cohort was also low (44% vs 80% expected). All women underwent elective C-section, resulting in a lower incidence of rupture uterus. A longer interpregnancy interval in the study participant also protected them against scar rupture.

The main strengths of the study were large sample size, stringent data collection, longer follow up and being conducted across many countries.

The study provides an important insight into epidemiological outcome of cesarean section, and concluding that no single method is superior over other. Most of the surgical techniques used during actual surgeries depends upon other considerations like surgeon’s personal choice, cost and time.

Dr. Marleen Temmerman from Aga Khan University, Nairobi, Kenya, and Ghent University, Ghent, Belgium, in an accompanying editorial conclude "For clinical practice, it is important to realize that all surgical techniques reported in this trial seem to be equally safe, which suggests that the rigorous use of the surgical techniques is more important than the technique as such. In view of the huge numbers of women undergoing this intervention, this report is important and long overdue.”

References:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30355-5/fulltext

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60441-9/fulltext

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00204-X/fulltext#sec1