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

University of Oslo (UIO)

Status: Enrolling

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

Treatments: Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap

Study type: Observational

Funder types: Other

Identifiers

NCT05689775

387180

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Patients

Description:

Patients over 18 years of age operated for locally advanced anal or rectal cancer with robot-assisted abdomino-perinal resection and robot-assisted reconstruction of pelvic floor and/or vagina with vertical rectus abdomínis muscle flap.

Treatment:

Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap