Perineum; WoundNCT05689775
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
An observational study of Perineum; Wound and Postoperative Complications, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perineum; Wound, Postoperative Complications, Rectal Neoplasms
- What is being tested?
- Reconstruction with robot-assisted rectus abdominis muscle flap
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with rectal or anal cancer
- scheduled for robot-assisted abdominoperineal resection
- reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital, Radiumhospitalet
Oslo, 0424
Lars Frich, MD, PhD, 004722930000, lfrich@ous-hf.no
About this study
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.
Read the 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
- Conditions
- Perineum; Wound, Postoperative Complications, Rectal Neoplasms, Rectus Abdominis Hernia, Prospective Studies, Wound Heal
- Being tested
- Reconstruction with robot-assisted rectus abdominis muscle flap
- Keywords
- Rectus abdominis muscle flap, Reconstruction, Perineum
- Medical subject headings
- Wounds and Injuries, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction with robot-assisted rectus abdominis muscle flapProcedure or surgery
Reconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap.
| Study group | Role | What they receive |
|---|---|---|
| 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 abdomínis muscle flap. Receives: Procedure: Reconstruction with robot-assisted rectus abdominis muscle flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
Early postoperative complications
Early postoperative complications at 30 days.
- Abdominal/donor-site complications
- superficial wound infection
- deep wound infection
- minor wound dehiscence
- major wound dehiscence
- abdominal hernia
- other complications
- 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
- 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.)
Measured: Within 30 days postoperatively
Late postoperative complications
Late postoperative complications
Perineal wound healing at 3 months.
- Abdominal/donor-site complications
- superficial wound infection
- deep wound infection
- minor wound dehiscence
- major wound dehiscence
- abdominal hernia
- other complications
- 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
- 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.)
Measured: Later than 30 days postoperatively
Quality of life - general
Quality of life - EORTC-QLQ-C30
Measured: Preoperatively. 3 months and 12 months postoperatively.
Quality of life - sexual
Quality of life - EORTC-QLQ-SH22 - excerpt
Measured: 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.
Measured: Preoperatively. 3 months and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineum; WoundStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Frich, Oslo University Hospital
- Investigators
- Lars Frich, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689775
- Sponsor's protocol ID
- 387180
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
- ClinicalTrials.gov ID
- NCT05689775
- Acronym / sponsor ID
- 387180
- Conditions
- Perineum; Wound, Postoperative Complications, Rectal Neoplasms, Rectus Abdominis Hernia, Prospective Studies, Wound Heal
- Keywords
- Rectus abdominis muscle flap, Reconstruction, Perineum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Reconstruction with robot-assisted rectus abdominis muscle flapPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with rectal or anal cancer
- scheduled for robot-assisted abdominoperineal resection
- reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconstruction with robot-assisted rectus abdominis muscle flapReconstruction of perineum and/or vagina with robot-assisted rectus abdominis muscle flap. | Procedure or surgery | Patients |
Primary outcome
Perineal wound healing
Time frame: 3 months
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
5 secondary outcomes
Early postoperative complications
Time frame: Within 30 days postoperatively
Late postoperative complications
Time frame: Later than 30 days postoperatively
Quality of life - general
Time frame: Preoperatively. 3 months and 12 months postoperatively.
Quality of life - sexual
Time frame: Preoperatively. 3 months and 12 months postoperatively.
Abdominal wall strength
Time frame: Preoperatively. 3 months and 12 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Frich, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineum; Wound and Postoperative Complications, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Frich, MD, PhD (004722930000, lfrich@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal wound healing (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.