Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
NCT ID: NCT05689775
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2022-09-01
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Reconstruction with robot-assisted rectus abdominis muscle flap
Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
Interventions
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Reconstruction with robot-assisted rectus abdominis muscle flap
Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
Eligibility Criteria
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Inclusion Criteria
* scheduled for robot-assisted abdominoperineal resection
* reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
Exclusion Criteria
* rectus abdominis muscle not available for harvest
* the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Lars Frich
Consultant
Principal Investigators
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Lars Frich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital, Radiumhospitalet
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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387180
Identifier Type: -
Identifier Source: org_study_id
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