IBD - Inflammatory Bowel Disease
Conditions
Keywords
Patients with inflammatory bowel disease (IBD), Colorectal surgery in IBD patients
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.
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.
Interventions
PROCEDURERobotic colorectal surgery
Colorectal surgery using robotic procedure
PROCEDURELaparoscopic colorectal surgery
Colorectal surgery using laparoscopic procedure
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | During the first 90 days postoperatively | Assessed using the Comprehensive Complication Index (CCI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to open surgery | Surgery day | Robotic/laparoscopic surgery to open surgery |
| 2. Postoperative pain | 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. |
| Quality of life (QoL) | At 30 and 90 days postoperatively | QoL using the SF-36 Physical Health Component |
| Costs | Till 90 days postoperatively | Direct Medical Costs (Hospital-Based) & Indirect Hospital Costs |
Countries
Belgium
Contacts
Primary ContactIsabelle Terrasson
Backup ContactBrent Cauwberghs, Dr
Outcome results
None listed