Randomized Multicenter Controlled Study of Endoscopic and Surgical Closure of a 4-cm Gaping Wide Colon Perforation in a Porcine Model

Abstract

Introduction & Aims: Colonoscopic perforation is a serious complication that requires emergency surgery. How about immediate colonoscopic closure as an alternative? We have shown that endoscopic clip closure of colon perforation is technically feasible & results in excellent healing; peritonitis & adhesions could be prevented by endoscopic clip closure with the InScope MultiClip Applier (IMCA) in a controlled trial; gaping wide colon perforations not amenable to clip closure can be closed with full-thickness sutures using tissue apposition system (TAS) (Raju et al GIE 2005-07). Our aim is to report the results of a randomized, multi-center, 2 wk survival study comparing endoscopic closure of a 4-cm gaping wide colon perforation with surgery. Of the 50 studies, 20 were completed at this time. Methods: 20 pigs with a 4-cm long, freshly created, full-thickness, gaping wide, colon perforation were randomized to endoscopic or surgical closure groups (ECG vs SCG). Endoscopic closure was accomplished with TAS ± IMCA. Surgical suture closure was accomplished after laparotomy. Endpoints: a) Technical feasibility of closure; b) Clinical recovery to normalcy in 6 hrs; c) 2 wk survival; d) Necropsy - day 14 for peritonitis, abscesses, adhesions & other complications; & e) Healing of perforation by leak test. Results: All the perforations were closed successfully. Of the 20 animals, 16 survived for 2 wks without complications; 1 in the ECG required additional endoscopic closure of suspected leak 4 hrs later - recovered slowly (necropsy @ 2wks: partial bowel obstruction); 3 were euthanized within 1 wk: 1) fecal peritonitis in the ECG (n = 1); 2) bowel obstruction from adhesions & 3) urinary bladder rupture from urethral ligation in the SCG (n = 2). ECG animals resumed normal activity in 6 hours, while SCG animals required 48 hrs to recover. Results are summarized in table 1. Conclusions: Endoluminal closure of a 4-cm gaping wide colon perforation is comparable to surgical closure. Endoscopic TAS ± IMCA application can close large perforations, prevent peritonitis, and the animals survive without complications. Recovery is quick after endoscopic closure. Close monitoring & immediate endoscopic reintervention may seal any ongoing leak. Tabled 1Comparison of endoscopic and surgical closure of a 4-cm gaping wide colon perforation Closure groups Successful closure Clinical recovery within six hrs 2 wk survival Peritoneal cavity Adhesion of intestine to ventral abdominal wall Leak test - no leak Endoscopy n = 10 10 8 9† 1 (feces) 1 (fibrin) 1 (abscess) 2 9/10∗ Surgery n = 10 10 0 8†† 1 (urine) 1 (fibrin) 1 (abscess) 7 9/10∗∗ p-value NS 0.001 NS NS NS NS † fecal peritonitis; †† bowel obstruction; & †† bladder rupture; ∗1/10: colon wound dehiscence; ∗∗1/10: colon suture abscess - leaked. Open table in a new tab † fecal peritonitis; †† bowel obstruction; & †† bladder rupture; ∗1/10: colon wound dehiscence; ∗∗1/10: colon suture abscess - leaked.