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

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

NCT ID: NCT05689775

Condition: Perineum; Wound
Postoperative Complications
Rectal Neoplasms
Rectus Abdominis Hernia
Prospective Studies
Wound Heal
Sexual Health

Conditions: Official terms:
Rectal Neoplasms
Postoperative Complications
Wounds and Injuries

Conditions: Keywords:
Rectus abdominis muscle flap
Reconstruction
Perineum

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Reconstruction with robot-assisted rectus abdominis muscle flap
Description: Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
Arm group label: Patients

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.

Detailed 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

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Oslo University Hospital, Radiumhospitalet

Address:
City: Oslo
Zip: 0424
Country: Norway

Status: Recruiting

Contact:
Last name: Lars Frich, MD, PhD

Phone: 004722930000
Email: lfrich@ous-hf.no

Start date: September 1, 2022

Completion date: December 31, 2026

Lead sponsor:
Agency: Oslo University Hospital
Agency class: Other

Source: Oslo University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05689775