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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 abdomÃnis muscle flap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconstruction with robot-assisted rectus abdominis muscle flap | Procedure | Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap. |
|
| 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.
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative complications | Early postoperative complications at 30 days. A. Abdominal/donor-site complications
B. Perineal complications
C. 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Frich, MD, PhD | Contact | 004722930000 | lfrich@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Lars Frich, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Radiumhospitalet | Recruiting | Oslo | 0424 | Norway |
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| Within 30 days postoperatively |
| Late postoperative complications | Late postoperative complications Perineal wound healing at 3 months. A. Abdominal/donor-site complications
B. Perineal complications
C. 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. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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