RecruitingNot ApplicableNCT06783244

Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery

Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery: A Double Blinded Randomized Clinical Trial


Sponsor

Victoria Rosberg

Enrollment

200 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing low versus standard abdominal gas pressure (pneumoperitoneum) during robot-assisted colorectal cancer surgery. Lower pressure may reduce pain and improve recovery while maintaining surgical visibility and quality. Patient quality of recovery will be measured after surgery. **You may be eligible if...** - You are 18 or older - You have colorectal cancer and are scheduled for robot-assisted surgery with curative intent **You may NOT be eligible if...** - Your BMI is above 35 - You need a stoma (temporary or permanent colostomy/ileostomy) - Your cancer has spread to other organs - You are receiving chemotherapy or radiation before surgery - You have had 3 or more previous abdominal operations - You are unable to complete a recovery questionnaire Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLow 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.


Locations(1)

Digestive Disease Center, Copenhagen University Hospital, Bispebjerg

Copenhagen NV, Denmark

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NCT06783244


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