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Background <p>Previously, the treatment of colorectal anastomotic insufficiencies with endoluminal vacuum therapy (EVT) was not feasible without creating a diverting stoma, as the suction sponge typically obstructed the intestinal lumen. However, clinical use of the VacStent GI™ in the upper gastrointestinal tract has demonstrated that secure closure of intestinal wall defects or anastomotic leaks, along with effective drainage of associated wound cavities, is achievable via intraluminal EVT. The innovative concept of the VacStent GI™ was now transferred to the lower GI tract.</p> Method <p>A prospective multicenter feasibility study was conducted, with the primary endpoint being the safe and practical application of the device, complete coverage of the leak, and effective suction-based treatment of colorectal leaks. Secondary endpoints included the prevention of septic complications, avoidance of stoma creation, successful leak healing, and the assessment of adverse events such as stent migration, local erosion or ulceration, and bleeding.</p> Results <p>Fourteen patients with postoperative colorectal anastomotic leaks and one with iatrogenic instrumental perforation were enrolled in two German hospitals. A total of 43 VacStent GI™ Colon were implanted, with a median of three VacStent per patient and a median treatment duration of 14&#xa0;days. The safe and practical application of the VacStent GI™ Colon was achieved in all implantations, resulting in a leak healing rate of 93.3% (14/15 patients). There were no severe device-related adverse events (SADE) nor significant local bleeding or erosion. The creation of a diverting stoma was not necessary in any of the patients.</p> <p>Minor stent-dislocation and migration, respectively, was observed in 4.7%. Three anastomotic stenoses were seen during follow-up.</p> Conclusion <p>Clinical use of the VacStent GI™ Colon&#xa0;in the lower gastrointestinal tract demonstrates that anastomotic colonic leaks can be effectively treated, potentially avoiding the need for a diverting stoma.</p>

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Treatment of colorectal leaks with the VACStent-Colon: results of the VACStent feasibility trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月4日

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  • Alexander Yohannes,
  • Jonas Lange,
  • Judith Knievel,
  • Marion Brunner,
  • Alois Fürst,
  • Ulrich Hügle,
  • Arno J. Dormann,
  • Claus F. Eisenberger,
  • Markus M. Heiss

摘要

Background

Previously, the treatment of colorectal anastomotic insufficiencies with endoluminal vacuum therapy (EVT) was not feasible without creating a diverting stoma, as the suction sponge typically obstructed the intestinal lumen. However, clinical use of the VacStent GI™ in the upper gastrointestinal tract has demonstrated that secure closure of intestinal wall defects or anastomotic leaks, along with effective drainage of associated wound cavities, is achievable via intraluminal EVT. The innovative concept of the VacStent GI™ was now transferred to the lower GI tract.

Method

A prospective multicenter feasibility study was conducted, with the primary endpoint being the safe and practical application of the device, complete coverage of the leak, and effective suction-based treatment of colorectal leaks. Secondary endpoints included the prevention of septic complications, avoidance of stoma creation, successful leak healing, and the assessment of adverse events such as stent migration, local erosion or ulceration, and bleeding.

Results

Fourteen patients with postoperative colorectal anastomotic leaks and one with iatrogenic instrumental perforation were enrolled in two German hospitals. A total of 43 VacStent GI™ Colon were implanted, with a median of three VacStent per patient and a median treatment duration of 14 days. The safe and practical application of the VacStent GI™ Colon was achieved in all implantations, resulting in a leak healing rate of 93.3% (14/15 patients). There were no severe device-related adverse events (SADE) nor significant local bleeding or erosion. The creation of a diverting stoma was not necessary in any of the patients.

Minor stent-dislocation and migration, respectively, was observed in 4.7%. Three anastomotic stenoses were seen during follow-up.

Conclusion

Clinical use of the VacStent GI™ Colon in the lower gastrointestinal tract demonstrates that anastomotic colonic leaks can be effectively treated, potentially avoiding the need for a diverting stoma.