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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Digestive Disease Center, Copenhagen University Hospital, Bispebjerg
Coordinator of this site? Confirm its status
Copenhagen NVDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.