Comparing low and standard abdominal pressure during robot-assisted colorectal cancer surgery
Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery: A Double Blinded Randomized Clinical Trial
This study is testing if using lower pressure during robot-assisted colorectal cancer surgery can help patients recover better and feel less pain afterwards.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen NV) |
| Trial ID | NCT06783244 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of low intraabdominal pressure (8 mmHg) versus standard pressure (12 mmHg) during robot-assisted surgery for colorectal cancer. The study focuses on assessing patient wellbeing post-surgery by measuring quality of recovery, pain levels, and analgesic consumption. Participants will complete the Quality of Recovery 15 questionnaire and report pain using a visual analog scale at various intervals after surgery. The goal is to determine if lower pressure improves recovery outcomes for patients undergoing this type of surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with colorectal cancer who are scheduled for curative robot-assisted surgery.
Not a fit: Patients with a BMI above 35, those unable to complete the QoR15 questionnaire, or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient recovery and reduce postoperative complications following colorectal cancer surgery.
How similar studies have performed: Previous studies have shown that enhanced recovery protocols and minimally invasive techniques can significantly improve postoperative outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 years * a diagnosis of colorectal cancer * scheduled for curative intended robot-assisted resection Exclusion Criteria: * 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
Where this trial is running
Copenhagen NV
- Digestive Disease Center, Copenhagen University Hospital, Bispebjerg — Copenhagen NV, Denmark (Recruiting)
Study contacts
- Study coordinator: Victoria Rosberg, Medical Doctor, PhD student
- Email: victoria.rosberg@regionh.dk
- Phone: 0045 22663778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.