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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Quality of recovery 15 (QoR15) questionnaire 8 hours after surgery — From end of surgery until 8 hours later
  The quality of recovery 15 (QoR15) questionnaire is a composite patient-centered rating scale measuring different important aspects of the postoperative recovery and fulfils the require-ments for outcome measurement instruments in clinical trials. The questionnaire consist of 15 questions, each being answered on a scale from 0-10. Thereby summed scores ranges from 0 to 150; 0 being the worst outcome and 150 being the best outcome. The questionnaire has been translated and validated in a Danish version and preserved the same validity, reliability, and high degree of responsiveness and clinical feasibility.

Trial sites (1)

Other trials for the same condition