Small bite continuous suture closure vs. mass closure of midline abdominal incision in emergency- A prospective, double-blind, multi-centric, randomized controlled trial

Incisional hernia results in significant morbidity anddecreased quality of life post operatively. Moreover, the treatment for repairis costly. Apart from patient related factors like malnutrition, obesity,smoking and post-operative wound infection, the surgical technique of woundclosure and suture material used could potentially be a major determinant ofpost-operative incisional Hernia. According to European hernia society (EHS)guideline small bite continuous suture with 2-0 PDS is recommended for closureof elective midline laparotomy incision.(1) The major RCT related to this recommendationwas “The STICH Trialâ€,conducted on 560 patients in Netherlands, over a period of three years, inthe patients undergoing elective laparotomy in the surgical and gynaecologicaldepartment.(2) The results was almost a 50% reduction in rate of incisionalhernia (21% to 13%). However, the follow up period was only one year althoughEHS recommends follow up of at least two years. The recently published MATCH review, a meta-analysis on“Materials and Techniques for Laparotomy Closureâ€, reviewed 1818 recordscollected through various database.(3) Only 23 RCTs could be included foranalysis as other was of not good quality or were biased. Thirteen studies haveincluded both emergency and elective midline laparotomies but none of themreported outcome data separately for emergency or elective subgroup. Only onestudy by Agrawal et al has compared only emergency laparotomies.(4) But theyhave compared two different types of sutures namely absorbable and non-absorbable. We could not find any good quality of literature comparing smallbite suture technique to mass closure in midline laparotomy incision inemergency. A similar view was mentioned by both MATCH reviewand European hernia society and hence they cannot frame a guideline onemergency wound closure technique. Considering the incidence ofincisional hernia as 15–20% of total laparotomies, which increases up to 35% inemergency laparotomies, incisional hernia should be considered as major causeof morbidity. High cost associated with the repair is another major concern.Small bite suture closure technique is now proposed as standard procedure inelective surgeries. We startedSMILE trail in 2019. The study’s hypothesis wasto use the small bite technique for emergency midline wound closure to reducethe rate of incisional hernias by approximately 50%.680 patients scheduled formidline laparotomy in emergency were planned for enrollment. They wererandomized to receive small bite closure with 2-0 PDS or large bites with loopPDS and followed-up for 3 years for the incisional hernia. The one-yearfollow-up data of 253 participants was analyzed by intention-to-treat approach. Twenty-nine patients died, 20 were re-operated, ten were lost to follow-up, andincomplete data were available in 11 patients and were excluded from theanalysis. Seven patients, although randomized in the small bite group, receivedthe closure with loop PDS. A total of 48(out of 253) patients developed incisionalhernia(28/107 in large bite, 20/146 in small bite,p =0.00). Diabetes mellitus,preoperative hemoglobin levels <10 g/dL, albumin <3 g/dL had aconsiderably higher risk of hernia. Multiple limitations were identified.Forty-six patients with malignancies were either re-operated or died due to theterminal disease and were unavailable for followup. The details of the woundlength vs. suture length were available only in 152 patients. Although thestudy started as a multicenter study, other centers could not start the trialdue to the COVID-19 pandemic. The number of incisional hernias were statistically less with small bitetechnique (13.7% vs 26.2%). However, interpretation is influenced by presenceof confounding variables. Considering multiple limitations during inclusion andfollow-up, the study is being stopped prematurely. We now plan to restart thetrial (SMILE 2.0) with modified protocol.