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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiport RObotic surgery | Active Comparator | Surgical procedure performed using a robotic system. |
|
| laparoscopic surgery | Active Comparator | Surgical method that uses a slender camera inserted through small incisions, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic colorectal surgery | Procedure | Colorectal surgery using robotic procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity | Assessed using the Comprehensive Complication Index (CCI) | During the first 90 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion to open surgery | Robotic/laparoscopic surgery to open surgery | 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Terrasson | Contact | +3216340837 | isabelle.terrasson@uzleuven.be | |
| Brent Cauwberghs, Dr | Contact | brent.cauwberghs@student.kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Gabriele Bislenghi, Professor | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abdominal Surgery | Recruiting | Leuven | Vlaams Brabant | 3000 | Belgium |
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| Laparoscopic colorectal surgery | Procedure | Colorectal surgery using laparoscopic procedure |
|
| First three postoperative days |
| Quality of life (QoL) | QoL using the SF-36 Physical Health Component | At 30 and 90 days postoperatively |
| Costs | Direct Medical Costs (Hospital-Based) & Indirect Hospital Costs | Till 90 days postoperatively |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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