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Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial
C Sabbagh1,2, F Mauvais3, M Demouron3
1Department of Digestive Surgery, Amiens University Medical Center, Amiens, France.
Background:
The value of a bridge in loop ileostomies is debated. We aimed to evaluate whether using a bridge when creating a loop ileostomy can reduce morbidity following an ileostomy.
Methods:
Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase 2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2 months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1 month and the STOMA-QOL score at 2 months.
Results:
During the study period, 67 patients were randomized to the bridge group and 63 to the no-bridge group. Epidemiological and perioperative data did not differ between the two groups. The stomal complication-free rate was 76% in the bridge group and 67% in the no-bridge group (p = 0.3). There was no difference in the distribution of complications at 1 month according to the Clavien-Dindo score (p = 0.2) or the STOMA-QOL score at 2 months (p = 0.4) between the two groups.
Conclusion:
The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients' quality of life.
Trial Registration Number:
NCT02756273 (May 10, 2016).
