Endoluminal Vacuum Therapy Using VACStent for Anastomotic Leak Management in Colorectal Surgery

Overview

This pilot study evaluated the feasibility, safety, and efficacy of the VACStent, a novel device combining vacuum therapy and covered stenting, for managing anastomotic leaks (AL) in colorectal surgery. The VACStent enabled effective drainage and wound healing while preserving intestinal passage, potentially avoiding stoma formation in selected patients.

Background

Anastomotic leak (AL) remains a serious complication in colorectal surgery, with incidence rates ranging from 2% to 39%, and is associated with increased morbidity, prolonged hospitalization, and reduced survival. Traditional management often involves stoma creation and sponge-assisted endoscopic vacuum therapy (EVT), which, while effective, frequently results in permanent stomas. Limitations of current EVT include bowel obstruction and high stent migration rates when covered stents are used alone. The VACStent was developed to overcome these challenges by combining a covered stent with vacuum-assisted drainage.

Data Highlights

Key Findings

• The VACStent combines a self-expanding covered stent with a polyurethane sponge connected to a vacuum pump, allowing continuous drainage and strong fixation to the intestinal wall.
• Application is performed transanally under endoscopic guidance with suction pressures between -80 and -125 mmHg.
• In the pilot study, VACStent use was feasible and safe in patients with AL and high-risk anastomoses, with no reported device migration due to suction fixation.
• The VACStent preserved intestinal passage, enabling fecal transit during therapy and potentially avoiding stoma formation.
• Early initiation of VACStent therapy correlated with improved wound healing and reduced morbidity.
• Preemptive intraoperative VACStent placement showed promise as an alternative to prophylactic stoma creation in high-risk patients.

Clinical Implications

The VACStent offers a minimally invasive option for managing colorectal anastomotic leaks by combining vacuum therapy with stenting, preserving bowel continuity and reducing the need for stoma formation. Early application in stable patients with AL or high-risk anastomoses may improve outcomes and decrease morbidity associated with traditional management. Clinicians should consider VACStent therapy as a novel tool in the multidisciplinary approach to colorectal anastomotic complications.

Conclusion

This pilot investigation demonstrates that VACStent therapy is a feasible, safe, and effective approach for managing anastomotic leaks and high-risk anastomoses in colorectal surgery, with the potential to avoid stoma formation. Further studies are warranted to confirm these findings and optimize patient selection.

References

1. Lange et al. 2023 -- VACStent: Combining EVT and Covered Stents in GI Tract
2. Clinical Trial Registry NCT04884334 -- VACStent Pilot Study