Robot-assisted reconstruction after surgery for rectal or anal cancer
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05689775 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with rectal or anal cancer scheduled for robotic-assisted abdominoperineal resection and subsequent reconstruction.
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.
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 performed: While similar robotic-assisted reconstruction techniques have shown promise, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Oslo
- 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
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.