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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
110
Colorectal surgery using robotic procedure
Colorectal surgery using laparoscopic procedure
Abdominal Surgery
Leuven, Vlaams Brabant, Belgium
RECRUITINGPostoperative morbidity
Assessed using the Comprehensive Complication Index (CCI)
Time frame: During the first 90 days postoperatively
Conversion to open surgery
Robotic/laparoscopic surgery to open surgery
Time frame: Surgery day
2. Postoperative pain
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.
Time frame: First three postoperative days
Quality of life (QoL)
QoL using the SF-36 Physical Health Component
Time frame: At 30 and 90 days postoperatively
Costs
Direct Medical Costs (Hospital-Based) \& Indirect Hospital Costs
Time frame: Till 90 days postoperatively
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