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Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap

Postoperative Complications Clinical Trial

Official title:
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap

Clinical Trial 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.

Clinical Trial Description

Inclusion criteria: Patients > 18 years of age operated with robotic-assisted abdominoperineal resection for irradiated locally advanced rectal or anal cancer where robotic-assisted perineal and/or vaginal reconstruction has been performed with a rectus abdominis muscle flap. Methods Up to 40 patients operated with robotic-assisted abdominoperineal resection with Da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, California, USA) and robotic-assisted reconstruction with a pedicled rectus muscle will be included in this prospective, non-randomized study. In addition to the standardized post-operative care for patients with locally advanced rectal or anal cancer as specified by national guidelines, patients will be offered study-specific follow-up visits at 1, 6 and 12 months. Complications are recorded by the accordion severity grading system of surgical complications. Patient related outcomes measures will be registered by using European organization for research and treatment of cancer Quality of life questionnaire Core 30 (EORTC QLQ-C30). Sexual health will be registered by a subset of questions from European organization for research and treatment of cancer Quality of life questionnaire Sexual health (EORTC QLQ-SH22). Primary endpoint: - perineal wound healing at 3 months Secondary endpoints: - early (< 30 days) and late (> 30 days) complications - quality of life preoperatively and at 3- and 12 months postoperatively - sexual function preoperatively and at 3- and 12 months postoperatively - clinical evaluation of abdominal wall strength preoperatively, at 3- and 12 months postoperatively ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05689775
Study type Observational [Patient Registry]
Source Oslo University Hospital
Contact Lars Frich, MD, PhD
Phone 004722930000
Email lfrich@ous-hf.no
Status Recruiting
Phase
Start date September 1, 2022
Completion date December 31, 2026
View Details
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