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

Inclusion Criteria3

  • age \>18 years
  • a diagnosis of colorectal cancer
  • scheduled for curative intended robot-assisted resection

Exclusion Criteria6

  • BMI above 35
  • inability to fulfill QoR15 questionnaire
  • construction of a stoma either proactive or permanent
  • metastatic cancer disease
  • recieving neoadjuvant treatment
  • previous multiple abdominal operations defined as 3 or more

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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