Safety and efficacy of prophylactic resorbable biosynthetic mesh in loop-ileostomy reversal: a case-control study.

Abstract

Loop ileostomy (LI) is a widely used temporary stoma technique. Reversal of LI is generally considered a minor and safe procedure, with very low short-term postoperative mortality and morbidity rates. Complications include incisional hernia (IH), carrying a high probability of surgical repair. Clinical measures to reduce the IH rate warrant consideration. Recent researches suggest the use of a prophylactic non-absorbable mesh to reduce IH rate; however, surgeons are reluctant to implant a permanent foreign material in contaminated operative fields, because of a higher risk of mesh-related complications, infection, seroma, and pain. The aim of the present study is to assess feasibility, potential benefits, and safety of a prophylactic biosynthetic mesh placed during LI reversal. From January 2016 to December 2018, 26 consecutive patients underwent LI reversal positioning a resorbable biosynthetic mesh in an on-lay position [mesh group (MG)]. The mesh used was a GORE BIO-A tissue reinforcement, a biosynthetic mesh composed of a bioabsorbable polyglycolide-trimethylene carbonate copolymer. The MG was matched with 58 patients [control group (CG)], undergoing LI reversal without mesh placement from January 2013 to December 2018. To detect IH, abdominal wall was studied according to clinical and ultrasonographic criteria. Primary endpoint was IH rate on LI site, at 6 and 12months after stomal reversal. Secondary endpoints included incidence of wound events. Thirty-day morbidity was classified according to Clavien-Dindo score; mortality and length of hospital stay were also collected. Mean follow-up was 15.4 ± 2.3months (range 12.4-22.0) for MG vs 37.2 ± 26.9 (range 24.9-49.7) for. CG. At 1year of follow-up, IH rate was lower in MG (n = 1/26 [3.8%]) vs CG (n = 19/58 [32.7%]; P < 0.05). A clinically evident IH was less frequent in MG (n = 0 [0%]) vs CG (n = 13 [68%]; P < 0.05). A radiologic IH was less frequent in MG (n = 1 [3%]) vs CG (n = 6 [31%]; P < 0.05). Stoma site hernia was repaired in 9/19 patients (47%) in CG; no patient of MG has hernia repaired. Incarcerated IH was observed in one patient of CG. No postoperative mortality was reported. Overall postoperative morbidity showed no difference comparing MG and MG (n = 5 [17%] vs n = 15 [19%], respectively; P > 0.05). Surgical site infections (SSI) were treated with antibiotic therapy, no debridement was necessary. Seroma occurred in two patients, one for each group. No statistically significant difference for surgical outcomes was found between the two groups at 30days. Early results of the present study suggest that an on-lay prophylactic placement of GORE BIO-A tissue reinforcement might lower IH rate at LI site. The procedure seems to be safe and effective, even long-term results and further studies are needed.