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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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<br>* Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectus abdominis muscle flap, Reconstruction, Perineum