Robot-assisted reconstruction after surgery for rectal or anal cancer
Official title: Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Run by Oslo University Hospital · NCT05689775 · Data updated 2026-11-12
This study is testing if using a muscle flap to rebuild the pelvic floor or vagina after robotic surgery for rectal or anal cancer can improve recovery and quality of life for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | December 31, 2024 |
| Study ends | December 31, 2026 |
| Registry record updated | January 19, 2023 |
| Trial ID | NCT05689775 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with rectal or anal cancer scheduled for robotic-assisted abdominoperineal resection and subsequent reconstruction.
✕Probably not a fit
Patients who are not eligible for robotic-assisted procedures or have unsuitable wound defects for reconstruction will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients over 18 years old who have undergone robotic-assisted abdominoperineal resection for locally advanced rectal or anal cancer. It evaluates the effectiveness of reconstructing the pelvic floor and/or vagina using a rectus abdominis muscle flap. The study will track operative time, complications, wound healing, abdominal wall strength, and patient-reported outcomes related to quality of life and sexual health. Follow-up visits will occur at 1, 6, and 12 months post-surgery to assess these outcomes.
Why it matters
Potential benefit: If successful, this approach could improve wound healing and quality of life for patients undergoing surgery for rectal or anal cancer.
How similar studies have gone: While similar robotic-assisted reconstruction techniques have shown promise, this specific approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with rectal or anal cancer * scheduled for robot-assisted abdominoperineal resection * reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap Exclusion Criteria: * patients not eligible for robot-assisted procedure * rectus abdominis muscle not available for harvest * the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap
Where it's running
-
Oslo University Hospital, Radiumhospitalet
Oslo, Norway Recruiting
Study contacts
- Principal investigator: Lars Frich, MD, PhD — Oslo University Hospital
- Study coordinator: Lars Frich, MD, PhD
- Email: lfrich@ous-hf.no
- Phone: 004722930000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.