OTSC System, OTSC Clips

OTSC® is associated with better procedural risk profile when compared to standard surgical correction in patients with non-resolving enterocutaneous fistula

In 7/10 patients with enterocutaneous fistula, OTSC application resulted in complete fistula closure. While NSQIP predicted rates of mortality, any complication, and median length of stay were 1.1 %, 34.5 %, and 9.5 days, respectively; patients successfully closed with OTSC experienced 0 mortalities, 0 complications, and had a median length of stay of 4 days.

J. Roy et al., Department of Surgery, University of South Alabama, Mobile, AL, USA, described their technical approach for OTSC closure of enterocutaneous fistulas (ECF) and the outcomes of ECF patients at their tertiary care hospital treated with OTSC between 07/2015 and 10/2017.

Enterocutaneous fistulas represent one of the most protracted and difficult problems in colorectal surgery with substantial morbidity and mortality. Closure rates without operative intervention in the era of advanced wound care and parenteral nutrition are markedly variable in reports, with most studies demonstrating closure rates in 30 – 35 % of cases. Conventional surgical intervention consists of extensive lysis of adhesions, bowel resection, and complex abdominal wall reconstruction and represents a potentially perilous endeavor. Mortality rates for ECF patients in different studies vary considerably but are as high as 10 – 20 %. Besides, ECF treatment is related to substantial costs for health care systems.

For the actual study, 10 patients (5 female, 5 male, average age 54.5 years, range 32 – 76) met the inclusion criteria. 7 patients had acute ECF (≤ 30 days old), 3 suffered from chronic ECF (> 30 days old). None of the patients had undergone prior abdominal or pelvic radiation. Median NSQIP-predicted risks for surgical correction of the fistula were 1.1 % for mortality, 34.5 % for periprocedural complications and 9.5 days for the length of stay.
Technical success was achieved in 9/10 OTSC applications. The overall clinical success rate for fistula closure was 70 %. Closure of acute fistulas resulted in an 86 % success rate (6/7), while closure of chronic fistulas resulted in a 33 % (1/3) success rate. There were no mortalities or operative complications associated with OTSC application, the median length of stay was 4 days.

The authors concluded that the OTSC is an effective adjunctive measure to improving rates of successful ECF closure. OTSC treatment of non-resolving ECFs can substantially decrease morbidity, hospitalization time, need for major surgical intervention, and possibly mortality.

Endoscopic technique for closure of enterocutaneous fistulas
Roy J, Sims K, Rider P, Grimm L, Hunter J, Richards W.
Surg Endosc. 2019 Oct;33(10):3464-3468. https://doi.org/10.1007/s00464-018-06646-1