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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689775
• Other study ID #: 387180
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2023
• Source: Oslo University Hospital
• Contact: Lars Frich, MD, PhD
• Phone: 004722930000
• Email: lfrich[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Prospective Studies
• Rectal Neoplasms
• Sexual Health
• Wound Heal
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Radiumhospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Quality of life - general	Quality of life - EORTC-QLQ-C30	Preoperatively. 3 months and 12 months postoperatively.
Secondary	Quality of life - sexual	Quality of life - EORTC-QLQ-SH22 - excerpt	Preoperatively. 3 months and 12 months postoperatively.
Secondary	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.