Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery
NCT06783244 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-04-29
Summary
The goal of this clinical trial is to investigate the influence of low intraabdominal pressure (compared to standard intraabdominal pressure) during robot-assisted colorectal cancer surgery on patients wellbeing after surgery. Patients included are diagnosed with colon- or rectal cancer, and scheduled for curatively intended surgery. The main question the trial aims to answer is:
Does low intraabdominal pressure during robot-assisted colorectal cancer surgery increase the patients wellbeing after surgery?
Researchers will compare low intraabdominal pressure (8 mmHg) to standard intraabdominal pressure (12 mmHg) to see if there is a difference in quality of recovery scores, pain scores and analgetic consumption.
Participants will be asked to fill out the Quality of Recovery 15 (QoR15) questionnaire 8 hours, 24 hours and 48 hours after surgery. Furthermore, patients will be asked to evaluate abdominal pain and shoulder tip pain using the visual analog scale (VAS).
Conditions
Interventions
- OTHER
-
Low intraabdominal pressure (8 mmHg)
Only difference in treatment is the lower level of intraabdominal pressure by which the procedure is performed. The intervention does not change the treatment. The surgical procedure is performed due to Danish national guidelines and remains the same in the two arms.
Sponsors & Collaborators
-
Victoria Rosberg
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-17
- Primary Completion
- 2026-06-15
- Completion
- 2027-01-15
Countries
- Denmark
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