Abdominal Surgery
Leuven, Vlaams Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT07230262
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Leuven, Vlaams Brabant, 3000, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1.4 Ileocecal/ileocolic resections 1.5 Segmental colectomies 1.6 Total colectomy 1.7 Proctocolectomy 1.8 Proctectomy
Exclusion criteria
Colorectal surgery using robotic procedure
Colorectal surgery using laparoscopic procedure
Time frame: During the first 90 days postoperatively
Assessed using the Comprehensive Complication Index (CCI)
Time frame: Surgery day
Robotic/laparoscopic surgery to open surgery
Time frame: 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.
Time frame: At 30 and 90 days postoperatively
QoL using the SF-36 Physical Health Component
Time frame: Till 90 days postoperatively
Direct Medical Costs (Hospital-Based) & Indirect Hospital Costs
Contact information is provided by the study sponsor or research team.
Brent Cauwberghs, Dr
CONTACT
Isabelle Terrasson
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients
Acronym: ACRO-IBD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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