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

A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients

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.

Study Overview

• Status: Recruiting
• Conditions: IBD - Inflammatory Bowel Disease
• Intervention / Treatment: Procedure: Robotic colorectal surgery; Procedure: Laparoscopic colorectal surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Terrasson; Phone Number: +3216340837; Email: isabelle.terrasson@uzleuven.be
• Study Contact Backup: Name: Brent Cauwberghs, Dr; Email: brent.cauwberghs@student.kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • Abdominal Surgery

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: multiport RObotic surgery; Surgical procedure performed using a robotic system.	Procedure: Robotic colorectal surgery; Colorectal surgery using robotic procedure
Active Comparator: laparoscopic surgery; Surgical method that uses a slender camera inserted through small incisions,	Procedure: Laparoscopic colorectal surgery; Colorectal surgery using laparoscopic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morbidity	Assessed using the Comprehensive Complication Index (CCI)	During the first 90 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion to open surgery	Robotic/laparoscopic surgery to open surgery	Surgery day
2. Postoperative pain	Pain measured according to the visual analogue scale (VAS). The minimum score is 0, the maximum score is 10. The lower the score (e.g. 1 or 2) the less pain; the higher the score (e.g. more than 7) the more pain.	First three postoperative days
Quality of life (QoL)	QoL using the SF-36 Physical Health Component	At 30 and 90 days postoperatively
Costs	Direct Medical Costs (Hospital-Based) & Indirect Hospital Costs	Till 90 days postoperatively

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Gabriele Bislenghi, Professor, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Patients with inflammatory bowel disease (IBD); Colorectal surgery in IBD patients
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: S70917 /B3222025001767/I/U

Drug and device information, study documents

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