European Journal of Molecular & Clinical Medicine

Abstract

This is a single-centre prospective, double-blind, randomized controlled comparative study
Methods
Prior written informed consent will be obtained from all the study subjects after explaining them the study protocol. Randomization for each patient will be predetermined by a random number generator and performed using random permuted blocks of size 10. Participants will be randomly assigned to undergo either single layered extra-mucosal intestinal anastomosis (Group-A) or double layered intestinal anastomosis (Group-B) by opening a sealed opaque envelope indicating the technique to be used. These envelopes will be  placed in the operating room and will be drawn sequentially just before surgery. At this point, each patient will be considered randomized. The study participants and the care providers who follow up the patients in the postoperative ward will be unaware of the type of anastomosis.
Results
In this study two patients who had developed anastomotic leak in group
B (double layer), among them 2(8%) patient responded well to conservative management and recovered. One more patient (4%) who had anastomotic leak in group B (double layer) died due to septicaemia and rest 22 patients (88%) were asymptomatic. In group A (single layer) two patient (8%) developed anastomotic leak and recovered with conservative management. p value if found out to be 0.14 and is not significant.
Conclusion
Duration required to perform a single layer intestinal anastomosis is significantly lesser when compared to double layer.
There is no significant difference in anastomotic leak between two groups.
There is no significant difference in duration of hospital stay in single vs double layered bowel anastomosis.