Clinical trial NCT05689775: Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Official title: Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perineum; Wound
Postoperative Complications
Rectal Neoplasms
Rectus Abdominis Hernia
Prospective Studies
Wound Heal
Sexual Health
Keywords: Rectus abdominis muscle flap
Reconstruction
Perineum
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Perineal wound healing
timeFrame: 3 months
Secondary outcomes:
measure: Early postoperative complications
timeFrame: Within 30 days postoperatively
measure: Late postoperative complications
timeFrame: Later than 30 days postoperatively
measure: Quality of life - general
timeFrame: Preoperatively. 3 months and 12 months postoperatively.
measure: Quality of life - sexual
timeFrame: Preoperatively. 3 months and 12 months postoperatively.
measure: Abdominal wall strength
timeFrame: Preoperatively. 3 months and 12 months postoperatively.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Radiumhospitalet
Study officials:
affiliation: Oslo University Hospital
name: Lars Frich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: