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

NCT07230262 | Recruiting DMC

• 1 other identifier: S70917 /B3222025001767/I/U
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBD - Inflammatory Bowel Disease

Keywords

Patients with inflammatory bowel disease (IBD); Colorectal surgery in IBD patients

Outcome Measures

Primary Outcomes (1)

• Postoperative morbidity

  Assessed using the Comprehensive Complication Index (CCI)

  During the first 90 days postoperatively

Secondary Outcomes (4)

• Conversion to open surgery

  Surgery day

• 2. Postoperative pain

  First three postoperative days

• Quality of life (QoL)

  At 30 and 90 days postoperatively

• Costs

  Till 90 days postoperatively

Study Arms (2)

multiport RObotic surgery

ACTIVE COMPARATOR

Surgical procedure performed using a robotic system.

Procedure: Robotic colorectal surgery

laparoscopic surgery

ACTIVE COMPARATOR

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

Procedure: Laparoscopic colorectal surgery

Interventions

Robotic colorectal surgery PROCEDURE

Colorectal surgery using robotic procedure

multiport RObotic surgery

Laparoscopic colorectal surgery PROCEDURE

Colorectal surgery using laparoscopic procedure

laparoscopic surgery

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Diagnosed with IBD and eligible for elective minimally invasive colorectal surgery, including:
• Ileocecal/ileocolic resections 1.5 Segmental colectomies 1.6 Total colectomy 1.7 Proctocolectomy 1.8 Proctectomy
• Procedures involving primary anastomosis or temporary or permanent stoma creation
• Suitable for minimally invasive surgery

You may not qualify if:

• Non IBD patients
• Urgent surgery (\<24 hours from hospital admission)
• Not suitable for minimally invasive surgery
• Ileoanal pouch construction

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Abdominal Surgery

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gabriele Bislenghi, Professor

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Terrasson

CONTACT

+3216340837; isabelle.terrasson@uzleuven.be

Brent Cauwberghs, Dr

CONTACT

brent.cauwberghs@student.kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-09

Locations

BE (1)