Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07230262

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abdominal Surgery

Leuven, Vlaams Brabant, 3000, Belgium

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

1.4 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

Exclusion criteria

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

Treatment and study plan

Robotic colorectal surgery

Procedure

Colorectal surgery using robotic procedure

Laparoscopic colorectal surgery

Procedure

Colorectal surgery using laparoscopic procedure

Primary outcomes

  1. Postoperative morbidity

    Time frame: During the first 90 days postoperatively

    Assessed using the Comprehensive Complication Index (CCI)

Secondary outcomes

  1. Conversion to open surgery

    Time frame: Surgery day

    Robotic/laparoscopic surgery to open surgery

  2. 2. Postoperative pain

    Time frame: First three postoperative days

    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.

  3. Quality of life (QoL)

    Time frame: At 30 and 90 days postoperatively

    QoL using the SF-36 Physical Health Component

  4. Costs

    Time frame: Till 90 days postoperatively

    Direct Medical Costs (Hospital-Based) & Indirect Hospital Costs

Study contacts

Contact information is provided by the study sponsor or research team.

Brent Cauwberghs, Dr

CONTACT

[email protected]

Isabelle Terrasson

CONTACT

[email protected]

+3216340837

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: ACRO-IBD

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.