VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery (VACURE)

VACStent Use for the Treatment of Anastomotic Leakage Following Colorectal Surgery: a Multicenter Prospective Efficacy Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Surgery; Stents; Vacuum Therapy; Endoscopy, Digestive System; Anastomotic Leak Rectum; Anastomotic Leakage; Minimal Invasive
• Intervention / Treatment: Device: VacStent GI Colon device

Detailed Description

Detailed description of device and study procedures:

The first step in the treatment of AL will focus on source control of intraperitoneal or extraperitoneal sepsis if needed. This can either be performed by surgical reintervention (relaparoscopy with or without diverting ostomy) and/or drainage procedures (radiological or endoscopic). The second step of the treatment will be the placement the CE-marked VacStent GI Colon (VacStent GI, VACStent GmbH, Fulda, Germany) to facilitate anastomotic healing. This device consists of a self-expanding nitinol stent surrounded by a polyurethane sponge.

Before VacStent placement, the anastomotic defect will be visualized and evaluated endoscopically. A submucosal saline solution ('marking') will be injected in the colon mucosa at least 2 cm distal to the defect. This marking will resolve within 30 minutes and serves as visual guide during placement of the stent. The endoscope will then be further introduced into the colon and a stiff guide wire will be inserted over the scope, approximately 15 cm proximal to the defect. The delivery system of the VacStent will subsequently be guided over the stiff guide wire under direct vision, allowing precise positioning over the anastomotic defect. The VacStent is stabilized by two catheters: an external catheter which keeps the stent compressed until positioned correctly, and an internal catheter which enables precise deployment. During employment, the distal flare of the VacStent will be positioned at the marking to ensure complete coverage of the defect by the cylindrical polyurethane sponge.

After correct placement, the delivery system and guide wire will be removed. The suction catheter will be guided out of the body transanally and connected to the VAC-pump. Continuous negative pressure of -125 mmHg will be applied. During the implementation phase at each participating center, a member of the coordinating team (Amsterdam UMC) and manufacturer will provide hands-on training for VacStent placement and removal. Prior to the study a meeting with procedural instruction will be organized.

The VacStent can stay in situ for approximately seven days. Thereafter it should be replaced or removed, depending on the endoscopic findings (Figure 3). To facilitate removal, the VAC-pump should be discontinued for at least six hours before the procedure. Also, the device should be flushed with 40 ml 0.9% NaCl prior to removal to minimize tissue adherence. The VacStent is removed by using a distal attachment cap applied to the endoscope. This ensures careful separation as it allows the endoscope to be maneuvered between the VacStent and the mucosa. The VacStent is then removed endoscopically by grasping the retrieval loops at the distal end of the VacStent with a grasping forceps. If the anastomosis has healed sufficiently, no new stent will be placed and VacStent therapy will be finished.

If no diverting ostomy was created before VacStent therapy, patients will receive osmotic laxatives three times per day (e.g., Movicol) and a fiber-free diet to maintain soft stool consistency. Routinely an endoscopy will be performed two weeks after removal of the VacStent, as well as a CT scan with rectal contrast enema six weeks after stent removal. This is the routine protocol after treatment of leaks to confirm healing of the AL at Amsterdam UMC. Functional outcomes following VacStent therapy will be assessed with the Low Anterior Resection Syndrome score (LARS score) and Health-related quality of life with the EQ-5D-5L questionnaire at 3, 6, and 12 months posttreatment. In case the patient was diagnosed with colorectal cancer, patients will receive two additional questionnaires (EORTC QLQ - CR29 and EORTC QLQ - CR30).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roel Hompes, MD, PhD; Phone Number: 020 444 4444; Email: r.hompes@amsterdamumc.nl
• Study Contact Backup: Name: Zoey Weerts, MD, MSc; Phone Number: 020 444 4444; Email: z.weerts@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC, location VUmc
    • Contact: Roel Hompes, MD, PhD; Phone Number: 020 444 4444; Email: r.hompes@amsterdamumc.nl
    • Contact: Zoey Weerts, MD, MSc; Phone Number: 020 444 4444; Email: z.weerts@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VacStent treatment; Treatment with the VacStent GI Colon device for Anastomotic Leakage	Device: VacStent GI Colon 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile: AE's and SAE's	Safety is defined as the occurrence of a maximum of one complication related to VacStent treatment, during VacStent treatment or within one day after removal of the VacStent, as defined by the AGREE classification grade 2 or higher. Grade 2: Adverse events requiring pharmacologic treatment with drugs other than those allowed for grade 1 adverse events (ie, antibiot-ics, antithrombotics, etc.) or; Blood or blood product transfusions Grade 3: adverse events requiring endoscopic, radiologic, or surgical in-tervention; Grade 3a: endoscopic or radiologic intervention; Grade 3b: adverse events requiring intensive care unit/critical care unit admission Grade 4: adverse events requiring intensive care unit/critical care unit admission; Grade 4a: single-organ dysfunction (including dialysis); Grade 4b: multiorgan dysfunction Grade 5: death of the patient	1 year
1-year stoma free-survival	Proportion of patients without a stoma	1 year
Temporary/permanent stoma	Proportion of patients with a temporary/permanent stoma	1 year
VacStent as sole therapy	Proportion of patients treated with VacStent as sole therapy	1 year
Time to complete anastomotic healing	Time to facilitate complete anastomotic healing	1 year
Reinterventions	Number of reinterventions required to facilitate anastomotic healing	1 year
Number of stents used	Number of VacStent used during treatment	1 year
Length of hospitalization and potential discharge	Length of hospital stay. Despite patients cannot be discharged during VAC stent treatment since it is not yet a homecare device, we will record the moment patients could be discharged. Discharge criteria are: independent in ADLs, sufficient pain control and normal oral intake.	1 year
Procedural complications	Surgical complications will be classified according to the Clavien-Dindo grading system. Endoscopic complications will be classified according to the AGREE classification.	30 days
Pain scores	Daily pain scores during VacStent treatment, assessed using the Visual Ana-logue Scale (VAS). Score ranges from 0-100 mm: 0 mm = no pain, 100 mm = worst pain ever	To the end of treatment, an average of 14 days
Functioning anastomoses	The percentage of functioning anastomoses at one year posttreatment.	1 year
Number of days admitted to the ICU	Number of days admitted to the ICU	1 year
Cost-effectiveness	Hospital costs associated with anastomotic leak management, including VacStent treatment	1 year
Health-Related Quality (EQ-5D-5L)	Health-Related Quality assessed by using the EQ-5D-5L. This is a short questionnaire to assess the global quality of life. Score ranges from 0-100: 0 = worst, 100 = best.	3 months, 6 months and 1 year posttreatment
Low Anterior Resection Syndrome score (LARS score)	A short questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer. Score ranges from 0-42: 0-20: no LARS 21-29: low LARS 30-42: high LARS	3 months, 6 months, and 1 year posttreatment
EORTC QLQ - CR29	A questionnaire to assess the quality of life in colorectal cancer patients. Score ranges from 0 to 100. Higher scores = better functioning on the functional scales and a higher level of symptoms on the symptom scales	3 months, 6 months, 1 year posttreatment
EORTC QLQ - CR30	A questionnaire to assess the quality of life in cancer patients. Score ranges from 0 and 100. For the functioning and the global QoL scales: a higher score indicates better health. For the symptoms scales: a higher score indicates more symptom burden.	3 months, 6 months, 1 year posttreatment

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Complications; Anastomotic Leak; Endoscopic vacuum therapy; Vacuum stent
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anastomotic Leak; Postoperative Complications
• Other Study ID Numbers: 2025.1211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD data (deidentified) underlying the results reported in publications may be made available to qualified researchers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No