RecruitingRecruiting
Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients (ACRO-IBD)
NCT07230262 · Universitaire Ziekenhuizen KU Leuven
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients
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.
Eligibility criteria
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 design
Enrollment target: 110 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-10-01
Estimated completion: 2028-12-01
Last updated: 2025-11-17
Interventions
Procedure: Robotic colorectal surgeryProcedure: Laparoscopic colorectal surgery
Primary outcomes
- • Postoperative morbidity (During the first 90 days postoperatively)
Sponsor
Universitaire Ziekenhuizen KU Leuven · other
Contacts & investigators
ContactIsabelle Terrasson · contact · isabelle.terrasson@uzleuven.be · +3216340837
ContactBrent Cauwberghs, Dr · contact · brent.cauwberghs@student.kuleuven.be
InvestigatorGabriele Bislenghi, Professor · principal_investigator, UZ Leuven
All locations (1)
Abdominal SurgeryRecruiting
Leuven, Vlaams Brabant, Belgium