VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery

NCT07631702 | Not Yet Recruiting

• 1 other identifier: 2025.1211
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL. Methods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.

Conditions

Colorectal Surgery; Endoscopy, Digestive System; Vacuum Therapy; Stents; Anastomotic Leakage; Minimal Invasive; Anastomotic Leak Rectum

Keywords

Postoperative Complications; Anastomotic Leak; Vacuum stent; Endoscopic vacuum therapy

Outcome Measures

Primary Outcomes (1)

• Successful VacStent treatment

  The proportion of patients successfully treated with the VacStent GI Colon device for colorectal AL. Successful treatment is defined by: the proportion of patients with complete healed anastomoses, confirmed by endoscopic assessment at two weeks posttreatment and radiologic assessment at 6 weeks posttreatment, without the need for further interventions.

  up to 6 weeks posttreatment

Secondary Outcomes (17)

• Safety profile: AE's and SAE's

  1 year

• 1-year stoma free-survival

  1 year

• Temporary/permanent stoma

  1 year

• VacStent as sole therapy

  1 year

• Time to complete anastomotic healing

  1 year

Study Arms (1)

VacStent treatment

EXPERIMENTAL

Treatment with the VacStent GI Colon device for Anastomotic Leakage

Device: VacStent GI Colon device

Interventions

VacStent GI Colon device DEVICE

The VacStent GI Colon device (VacStent GI, VACStent GmbH, Fulda, Germany) is designed to treat colorectal AL and allows continued fecal passage through the stent. By combining the advantages of endoscopic vacuum therapy (EVT) with the mechanical stability of a stent, it promotes wound healing while maintaining luminal patency.

VacStent treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AL in the distal sigmoid, upper or mid rectum following a colorectal resection
• ≥ 18 years old.
• Signed a written informed consent

You may not qualify if:

• Anastomosis that is not endoscopically accessible.
• Contra-indications for VacStent GI therapy: (a) Significant tissue ischemia in the area of the wound cavity, larger than the length of the VacStent GI Colon; (b) Anastomotic defect located \<4 cm from the dentate line. This is considered a relative contraindication, as very distal placement may cause patient discomfort although not necessarily; (c) Severe coagulopathy; (d) Ileus that does not allow for endoscopic examination.
• Anastomotic fistula to surrounding organs (vagina, bladder, small bowel)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Anastomotic Leak; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roel Hompes, MD, PhD

CONTACT

020 444 4444; r.hompes@amsterdamumc.nl

Zoey Weerts, MD, MSc

CONTACT

020 444 4444; z.weerts@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, multicenter efficacy study

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: June 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

NL (1)