Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients (ACRO-IBD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-12-01

Brief Summary

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The aim of this study is to better understand whether robotic surgery leads to better outcomes than laparoscopy in terms of complications, recovery and quality of life.

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Detailed Description

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This clinical trial compares two surgical techniques, robotic surgery and conventional laparoscopic surgery, for patients with inflammatory bowel disease (IBD) requiring elective colorectal surgery. Both approaches are minimally invasive and commonly used in clinical practice. This is a randomized trial: participants will be randomly assigned to one of the two techniques. A total of 110 patients will be enrolled.

This study will evaluate the role of robotic surgery in the surgical treatment of inflammatory bowel disease.

Three quality-of-life questionnaires will be completed: before the procedure and at 30 and 90 days post-procedure. Pain will also be assessed during the first three days post-procedure using a specific score called the VAS.

This study will be conducted exclusively at the University Hospitals Leuven.

Conditions

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IBD - Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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multiport RObotic surgery

Surgical procedure performed using a robotic system.

Group Type ACTIVE_COMPARATOR

Robotic colorectal surgery

Intervention Type PROCEDURE

Colorectal surgery using robotic procedure

laparoscopic surgery

Surgical method that uses a slender camera inserted through small incisions,

Group Type ACTIVE_COMPARATOR

Laparoscopic colorectal surgery

Intervention Type PROCEDURE

Colorectal surgery using laparoscopic procedure

Interventions

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Robotic colorectal surgery

Colorectal surgery using robotic procedure

Intervention Type PROCEDURE

Laparoscopic colorectal surgery

Colorectal surgery using laparoscopic procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. Diagnosed with IBD and eligible for elective minimally invasive colorectal surgery, including:

1.4 Ileocecal/ileocolic resections 1.5 Segmental colectomies 1.6 Total colectomy 1.7 Proctocolectomy 1.8 Proctectomy
4. Procedures involving primary anastomosis or temporary or permanent stoma creation
5. Suitable for minimally invasive surgery

Exclusion Criteria

1. Non IBD patients
2. Urgent surgery (\<24 hours from hospital admission)
3. Not suitable for minimally invasive surgery
4. Ileoanal pouch construction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No