NCT06783244Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 17 Feb 2025
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Victoria Rosberg
- Diseases
- Colorectal cancer
- NCT number
- NCT06783244
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 17 Feb 2025 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous multiple abdominal operations defined as 3 or more
Other illness
- metastatic cancer disease
Other
- BMI above 35
- inability to fulfill QoR15 questionnaire
- construction of a stoma either proactive or permanent
- recieving neoadjuvant treatment
Who the study is looking for
- age \>18 years
- a diagnosis of colorectal cancer
- scheduled for curative intended robot-assisted resection
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Digestive Disease Center, Copenhagen University Hospital, Bispebjerg Coordinator of this site? Confirm its status | Copenhagen NV | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.