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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with rectal or anal cancer

scheduled for robot-assisted abdominoperineal resection

reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Reconstruction with robot-assisted rectus abdominis muscle flap

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

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

Time frame
3 months

Secondary outcomes

1

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.)

Time frame
Within 30 days postoperatively
2

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.)

Time frame
Later than 30 days postoperatively
3

Quality of life - general

Quality of life - EORTC-QLQ-C30

Time frame
Preoperatively. 3 months and 12 months postoperatively.
4

Quality of life - sexual

Quality of life - EORTC-QLQ-SH22 - excerpt

Time frame
Preoperatively. 3 months and 12 months postoperatively.

Other outcomes

Sponsors and contacts

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