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

Recruiting

• Conditions: Postoperative Complications; Rectus Abdominis Hernia; Prospective Studies; Perineum; Wound; Sexual Health; Rectal Neoplasms; Wound Heal
• Interventions: Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap

• Registration Number: NCT05689775
• Lead Sponsor: Oslo University Hospital

Brief 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

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-11-23
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Reconstruction with robot-assisted rectus abdominis muscle flap	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.

Primary Outcome Measures

Name	Time	Method
Perineal wound healing	3 months	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 Outcome Measures

Name	Time	Method
Late postoperative complications	Later than 30 days postoperatively	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	Preoperatively. 3 months and 12 months postoperatively.	Quality of life - EORTC-QLQ-C30
Early postoperative complications	Within 30 days postoperatively	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.)
Quality of life - sexual	Preoperatively. 3 months and 12 months postoperatively.	Quality of life - EORTC-QLQ-SH22 - excerpt
Abdominal wall strength	Preoperatively. 3 months and 12 months postoperatively.	Clinical test of abdominal wall strength as described in (Nelson JA et al. Function and strength after free abdominally based breast reconstruction: A 10-year follow- up. Plastic and reconstructive surgery. 2019;143(1):22e-31e.

Trial Locations

Locations (1)

Oslo University Hospital, Radiumhospitalet; 🇳🇴 Oslo, Norway