Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients (ACRO-IBD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic colorectal surgery, Laparoscopic colorectal surgery.
- Who it may be relevant to
- Registry conditions: IBD - Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients
Overview
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
- Procedure Robotic colorectal surgery
Colorectal surgery using robotic procedure - Procedure Laparoscopic colorectal surgery
Colorectal surgery using laparoscopic procedure
Primary outcome measures
- Postoperative morbidity [Time frame: During the first 90 days postoperatively]
Secondary outcome measures (4)
- Conversion to open surgery [Time frame: Surgery day]
- 2. Postoperative pain [Time frame: First three postoperative days]
- Quality of life (QoL) [Time frame: At 30 and 90 days postoperatively]
- Costs [Time frame: Till 90 days postoperatively]
Eligibility criteria
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
- Non IBD patients
- Urgent surgery (<24 hours from hospital admission)
- Not suitable for minimally invasive surgery
- Ileoanal pouch construction
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Abdominal Surgery — Leuven
Identifiers
NCT: NCT07230262 · S70917 /B3222025001767/I/U