Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial

The hand-sewn method of bowel anastomosis is the most common because of its affordability, familiarity and easy availability of materials. It can be done in single or double layers, with different surgeons preferring one technique over the other. Double layer intestinal anastomosis (DLIA) is time-consuming, challenging to perform, and carries possibly a higher risk of devascularisation, infection, and necrosis. Studies conducted so far do not show a significant difference between the two, but have concluded that more studies are required to determine this definitively. This study attempted to see whether the single layer intestinal anastomosis (SLIA) is non-inferior to DLIA in terms of incidence of anastomotic leak. It also compared mortality, morbidity, and length of hospitalization (LOH) between the two groups. This was a parallel arm, open labelled, non-inferiority randomized controlled trial conducted in the department of surgery in a tertiary care centre between October 2016 and March 2018. Patients who fulfilled the inclusion criteria were randomly allotted to two groups: Patients undergoing SLIA and patients undergoing DLIA. After the procedure, all patients were assessed for anastomotic leak, morbidity, mortality and LOH in the postoperative period. A 3-month follow-up period was observed for complications. A total of 106 patients were randomised, 52 in SLIA and 54 in DLIA. Baseline demographic and clinicopathological characteristics between the two groups were comparable. The most common indication for intestinal anastomosis was ostomy closure in both groups. There was no significant difference between the two groups in terms of anastomotic leak, other complications, mortality and LOH. SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings. •Hand-sewn bowel anastomoses can be done either in two layers or one layer.•Single layer anastomosis is shown to be time & cost-effective.•This was a randomised controlled trial with single layer anastomoses as the intervention and double layer as the control.•Incidence of anastomotic leak and other complications were equal across both groups.•Single layer anastomosis can be safely performed instead of double layer anastomosis.