NCT05689775 Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
| NCT ID | NCT05689775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Perineum; Wound |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-09-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.
Eligibility 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
Contact & Investigator
Lars Frich, MD, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT05689775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Perineum; Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05689775 currently recruiting?
Yes, NCT05689775 is actively recruiting participants. Contact the research team at lfrich@ous-hf.no for enrollment information.
Where is the NCT05689775 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT05689775 clinical trial?
NCT05689775 is sponsored by Oslo University Hospital. The principal investigator is Lars Frich, MD, PhD at Oslo University Hospital. The trial plans to enroll 40 participants.