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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Lars Frich, MD, PhD; Phone Number: 004722930000; Email: lfrich@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital, Radiumhospitalet
    • Contact: Lars Frich, MD, PhD; Phone Number: 004722930000; Email: lfrich@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; 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.	Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap; Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Within 30 days postoperatively
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.)	Later than 30 days postoperatively
Quality of life - general	Quality of life - EORTC-QLQ-C30	Preoperatively. 3 months and 12 months postoperatively.
Quality of life - sexual	Quality of life - EORTC-QLQ-SH22 - excerpt	Preoperatively. 3 months and 12 months postoperatively.
Abdominal wall strength	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.	Preoperatively. 3 months and 12 months postoperatively.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Lars Frich, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Estimate): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Reconstruction; Perineum; Rectus abdominis muscle flap
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Wounds and Injuries; Rectal Neoplasms; Postoperative Complications
• Other Study ID Numbers: 387180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No