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

NCT06783244 | Recruiting DMC

• 1 other identifier: H-24073961
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; robot-assisted surgery; intraabdominal pressure

Outcome Measures

Primary Outcomes (1)

• Quality of recovery 15 (QoR15) questionnaire 8 hours after surgery

  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.

  From end of surgery until 8 hours later

Secondary Outcomes (13)

• QoR15 questionnaire 24 og 48 hours after surgery

  From end of surgery until 24 and 48 hours later

• Postoperative pain score

  From end of surgery until at 8 hours, 24 hours and 48 hours after surgery

• Postoperative opioid consumption

  End of surgery until 3 days after surgery. Assessed up to 6 months after surgery.

• Change in intraabdominal pressure during surgery

  From operation start until end of surgery. Assessed up to 6 months after surgery.

• Operation time

  From operation start until end of surgery. Assessed up to 6 months after surgery.

Study Arms (2)

Low pressure (8 mmHg)

ACTIVE COMPARATOR

Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with low intraabdominal pressure (8 mmHg)

Other: Low intraabdominal pressure (8 mmHg)

Standard pressure (12 mmHg)

NO INTERVENTION

Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with standard intraabdominal pressure (12 mmHg)

Interventions

Low intraabdominal pressure (8 mmHg) OTHER

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.

Low pressure (8 mmHg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Victoria Rosberg: lead

Study Sites (1)

Digestive Disease Center, Copenhagen University Hospital, Bispebjerg

Copenhagen NV, 2400, Denmark

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Victoria Rosberg, Medical Doctor, PhD student

CONTACT

0045 22663778; victoria.rosberg@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor and PhD student

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 20, 2025
• Study Start: February 17, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

DK (1)