Incisional hernia results in significant morbidity and decreased quality of life post operatively. Moreover, the treatment for repair is costly. Apart from patient related factors like malnutrition, obesity, smoking and post-operative wound infection, the surgical technique of wound closure and suture material used could potentially be a major determinant of post-operative incisional Hernia. According to European hernia society (EHS) guideline small bite continuous suture with 2-0 PDS is recommended for closure of elective midline laparotomy incision.(1) The major RCT related to this recommendation was “The STICH Trial”, conducted on 560 patients in Netherlands, over a period of three years, in the patients undergoing elective laparotomy in the surgical and gynaecological department.(2) The results was almost a 50% reduction in rate of incisional hernia (21% to 13%). However, the follow up period was only one year although EHS recommends follow up of at least two years. The recently published MATCH review, a meta-analysis on “Materials and Techniques for Laparotomy Closure”, reviewed 1818 records collected through various database.(3) Only 23 RCTs could be included for analysis as other was of not good quality or were biased. Thirteen studies have included both emergency and elective midline laparotomies but none of them reported outcome data separately for emergency or elective subgroup. Only one study by Agrawal et al has compared only emergency laparotomies.(4) But they have compared two different types of sutures namely absorbable and non- absorbable. We could not find any good quality of literature comparing small bite suture technique to mass closure in midline laparotomy incision in emergency. A similar view was mentioned by both MATCH review and European hernia society and hence they cannot frame a guideline on emergency wound closure technique. Considering the incidence of incisional hernia as 15–20% of total laparotomies, which increases up to 35% in emergency laparotomies, incisional hernia should be considered as major cause of morbidity. High cost associated with the repair is another major concern. Small bite suture closure technique is now proposed as standard procedure in elective surgeries. We started SMILE trail in 2019. The study’s hypothesis was to use the small bite technique for emergency midline wound closure to reduce the rate of incisional hernias by approximately 50%.680 patients scheduled for midline laparotomy in emergency were planned for enrollment. They were randomized to receive small bite closure with 2-0 PDS or large bites with loop PDS and followed-up for 3 years for the incisional hernia. The one-year follow-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, and incomplete data were available in 11 patients and were excluded from the analysis. Seven patients, although randomized in the small bite group, received the closure with loop PDS. A total of 48(out of 253) patients developed incisional hernia(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 a considerably higher risk of hernia. Multiple limitations were identified. Forty-six patients with malignancies were either re-operated or died due to the terminal disease and were unavailable for followup. The details of the wound length vs. suture length were available only in 152 patients. Although the study started as a multicenter study, other centers could not start the trial due to the COVID-19 pandemic.
The number of incisional hernias were statistically less with small bite technique (13.7% vs 26.2%). However, interpretation is influenced by presence of confounding variables. Considering multiple limitations during inclusion and follow-up, the study is being stopped prematurely. We now plan to restart the trial (SMILE 2.0) with modified protocol.