Background <p>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.</p> Methods <p>Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase&#xa0;2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2&#xa0;months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1&#xa0;month and the STOMA-QOL score at 2&#xa0;months.</p> Results <p>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 (<i>p</i> = 0.3). There was no difference in the distribution of complications at 1&#xa0;month according to the Clavien–Dindo score (<i>p</i> = 0.2) or the STOMA-QOL score at 2&#xa0;months (<i>p</i> = 0.4) between the two groups.</p> Conclusion <p>The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients’ quality of life.</p> Trial registration number <p>NCT02756273 (May 10, 2016).</p>

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Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial

  • C. Sabbagh,
  • F. Mauvais,
  • M. Demouron,
  • F. Browet,
  • L. Tartar,
  • H. Hariz,
  • V. Bridoux,
  • J.-J. Tuech,
  • M. Diouf,
  • J.-M. Regimbeau

摘要

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).