Robotic versus laparoscopic colorectal surgery for people with IBD
A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients
Adults with IBD who need elective colorectal surgery will be randomly assigned to robotic or conventional laparoscopic surgery to see if robotic surgery reduces complications and improves recovery and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams Brabant) |
| Trial ID | NCT07230262 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center trial will enroll 110 adults with inflammatory bowel disease who require elective minimally invasive colorectal resections and assign them to either multiport robotic or conventional laparoscopic surgery. Both approaches are minimally invasive and commonly used in practice; outcomes include surgical complications, recovery metrics, pain (VAS during the first three days), and quality-of-life questionnaires completed before surgery and at 30 and 90 days. The trial directly compares postoperative complication rates and patient-reported recovery between the two surgical techniques. All procedures and follow-up are conducted at University Hospitals Leuven.
Who should consider this trial
Good fit: Adults (18 or older) diagnosed with IBD who are scheduled for elective minimally invasive colorectal resections and are suitable candidates for either robotic or laparoscopic surgery are ideal participants.
Not a fit: Patients requiring urgent surgery, those not suitable for minimally invasive approaches, non-IBD patients, and those needing ileoanal pouch construction are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, this could show that robotic surgery leads to fewer complications, faster recovery, and better short-term quality of life after elective colorectal operations for IBD patients.
How similar studies have performed: Robotic colorectal surgery has shown some benefits in selected non-IBD colorectal populations, but randomized evidence specific to IBD patients is limited, making this comparison relatively novel for this group.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams Brabant
- Abdominal Surgery — Leuven, Vlaams Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Gabriele Bislenghi, Professor — UZ Leuven
- Study coordinator: Isabelle Terrasson
- Email: isabelle.terrasson@uzleuven.be
- Phone: +3216340837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.