Actively Recruiting
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Led by Oslo University Hospital · Updated on 2023-01-19
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with locally advanced rectal or anal cancer who have undergone robotic-assisted abdominoperineal resection followed by reconstruction using a rectus abdominis muscle flap. The study aims to evaluate the surgery's effects on wound healing, abdominal wall strength, complications, quality of life, and sexual health. It is a prospective, non-randomized observational study conducted by Oslo University Hospital. Participants will receive robotic-assisted reconstruction of the perineum and/or vagina using a rectus abdominis muscle flap performed with the Da Vinci Xi surgical system. Up to 40 patients undergoing this specific surgical procedure will be included. In addition to standard postoperative care, study-specific follow-up visits are scheduled at 1, 6, and 12 months after surgery to monitor recovery and outcomes. Throughout the study, researchers will record complications using a standardized grading system and assess patient-reported quality of life using validated questionnaires. Sexual health will be evaluated with a dedicated subset of questions. Abdominal wall strength and wound healing will be clinically examined before surgery and at 3 and 12 months postoperatively. The main outcome measured is the status of perineal wound healing at 3 months, with other postoperative complications and patient-related outcomes tracked over time.
CONDITIONS
Brief Title
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with rectal or anal cancer
- Scheduled for robot-assisted abdominoperineal resection
- Undergoing reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
You will not qualify if you...
- Patients not eligible for robot-assisted procedure
- Rectus abdominis muscle not available for harvest
- Expected wound defect not suitable for reconstruction with rectus abdominis muscle flap
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration as per routine care
Participants undergo robot-assisted abdominoperineal resection and reconstruction with a rectus abdominis muscle flap, followed by standardized post-operative care.
Surgery day and immediate hospitalization period
Duration - 12 months
Participants attend study-specific follow-up visits to monitor wound healing, complications, quality of life, sexual function, and abdominal wall strength.
Follow-up visits at 1 month, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Oslo University Hospital, Radiumhospitalet
Oslo, Norway, 0424
Actively Recruiting
Research Team
L
Lars Frich, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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