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

NCT05689775 | Recruiting

• 1 other identifier: 387180
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Rectus abdominis muscle flap; Reconstruction; Perineum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Early postoperative complications

  Within 30 days postoperatively

• Late postoperative complications

  Later than 30 days postoperatively

• Quality of life - general

  Preoperatively. 3 months and 12 months postoperatively.

• Quality of life - sexual

  Preoperatively. 3 months and 12 months postoperatively.

• Abdominal wall strength

  Preoperatively. 3 months and 12 months postoperatively.

Study Arms (1)

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

Interventions

Reconstruction with robot-assisted rectus abdominis muscle flap PROCEDURE

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients with rectal or anal cancer
• scheduled for robot-assisted abdominoperineal resection
• reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Radiumhospitalet

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Postoperative Complications; Rectal Neoplasms

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Lars Frich, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Frich, MD, PhD

CONTACT

004722930000; lfrich@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: January 19, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

NO (1)