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NCT Number: NCT05689775

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.

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Key information

Conditions

Perineum; Wound Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prospective Studies Rectal Diseases Rectal Neoplasms Rectus Abdominis Hernia Sexual Health Wound Heal Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Radiumhospitalet

Oslo, 0424, Norway

Location status: Recruiting

Location contact

Lars Frich, MD, PhD

CONTACT

[email protected]

004722930000

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconstruction with robot-assisted rectus abdominis muscle flap

Procedure

Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.

Primary outcomes

  1. Perineal wound healing

    Time frame: 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 outcomes

  1. Early postoperative complications

    Time frame: 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.)

  2. Late postoperative complications

    Time frame: 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.)

  3. Quality of life - general

    Time frame: Preoperatively. 3 months and 12 months postoperatively.

    Quality of life - EORTC-QLQ-C30

  4. Quality of life - sexual

    Time frame: Preoperatively. 3 months and 12 months postoperatively.

    Quality of life - EORTC-QLQ-SH22 - excerpt

  5. Abdominal wall strength

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Frich, MD, PhD

CONTACT

[email protected]

004722930000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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