About this trial
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
This trial does not accept healthy volunteersQualifiers
patients with rectal or anal cancer
scheduled for robot-assisted abdominoperineal resection
reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
Disqualifiers
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
Trial population
Patients with rectal or anal cancer who are scheduled for robot-assisted abdominoperineal resection who need reconstruction of pelvic floor and/or vagina with rectus abdomens muscle flap.
Trial design
Cohort
Prospective
Treatments tested in this trial
Reconstruction with robot-assisted rectus abdominis muscle flap
Procedure/SurgeryReconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
Treatment groups
Trial outcomes
Primary outcomes
Perineal wound healing
Perineal wound healing at 3 months. Perineal wound has completely healed at clinical control 3 months postoperatively without need for further follow-up of the perineal wound. Any perineal complications are noted. * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * partial flap loss * total flap loss * perineal hernia * enterocutaneous fistula * stricture in neovagina * perineal wound dehiscence not related to flap * other complications
Secondary outcomes
Early postoperative complications
Early postoperative complications at 30 days. A. Abdominal/donor-site complications * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * abdominal hernia * other complications B. Perineal complications * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * partial flap loss * total flap loss * perineal hernia * enterocutaneous fistula * stricture in neovagina * perineal wound dehiscence not related to flap * other complications C. Other complications * incisional hernia * parastomal hernia * reoperation * other complications Complications are classified as mild, moderate or severe according to Accordion severity grading system (Strasberg SM, Linehan DC, Hawkins WG. The Accordion severity grading system of surgical complications. Ann Surg 2009; 250: 177-86.)
Late postoperative complications
Late postoperative complications Perineal wound healing at 3 months. A. Abdominal/donor-site complications * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * abdominal hernia * other complications B. Perineal complications * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * partial flap loss * total flap loss * perineal hernia * enterocutaneous fistula * stricture in neovagina * perineal wound dehiscence not related to flap * other complications C. Other complications * incisional hernia * parastomal hernia * reoperation * other complications Complications are classified as mild, moderate or severe according to Accordion severity grading system (Strasberg SM, Linehan DC, Hawkins WG. The Accordion severity grading system of surgical complications. Ann Surg 2009; 250: 177-86.)
Quality of life - general
Quality of life - EORTC-QLQ-C30
Quality of life - sexual
Quality of life - EORTC-QLQ-SH22 - excerpt
Sponsors and contacts
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