Rectal CancerNCT04334421
APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
An observational study of Rectal Cancer and Abdominoperineal Resection, run by Elisa Mäkäräinen at 1 site in Finland.
Trial summary
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Abdominoperineal Resection, Wound Heal
- What is being tested?
- Composite mesh
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 3 Apr 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All study patients who have abdominoperineal resection
Who may be able to join
- Abdominoperineal resection and permanent colostoma
Who cannot join
- Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
- Potentially curable resection not possible
- Patient undergoing emergency procedure
- Metastatic disease
- Pregnant or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.
Previous studies on synthetic mesh repair on perineum are almost lacking.
Read the detailed description
The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.
30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.
- Conditions
- Rectal Cancer, Abdominoperineal Resection, Wound Heal
- Being tested
- Composite mesh
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite meshDevice
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
| Study group | Role | What they receive |
|---|---|---|
| Mesh group | After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap. Receives: Device: Composite mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication index
Comprehensive Complication index is used to evaluate outcome
Measured: 30 days
Secondary outcomes (8)
Surgical site infection
Surgical site infection classified by Clavien-Dindo score
Measured: 30 days
Reoperation rate
Reoperations during primary stay at the hospital
Measured: 30 days
Operative time
Operative time
Measured: 30 days
Length of stay
Length of stay at the hospital during primary operation and recovery
Measured: 30 days
Costs
Costs by materials used
Measured: 30 days
Total perineal healing time
Time to point when perineum is closed and healed
Measured: 30 days
Perineal sinus
Presence of perineal sinus at 30 days follow-up
Measured: 30 days
Perineal hernia
Perineal hernia by CT scan at 12 months follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start3 Apr 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisa Mäkäräinen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elisa Mäkäräinen, University of Oulu
- Investigators
- Elisa Mäkäräinen-Uhlbäck, M.D., Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334421
- Sponsor's protocol ID
- 57/2020
- Status last verified
- Jan 2024
- First submitted
- 1 Apr 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
- ClinicalTrials.gov ID
- NCT04334421
- Acronym / sponsor ID
- 57/2020
- Conditions
- Rectal Cancer, Abdominoperineal Resection, Wound Heal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elisa MäkäräinenUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Apr 2020 (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.
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.
Previous studies on synthetic mesh repair on perineum are almost lacking.
Detailed description
The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.
30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesh group | – | Device: Composite meshAfter resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study patients who have abdominoperineal resection
Key inclusion criteria (1 listed)
- Abdominoperineal resection and permanent colostoma
Key exclusion criteria (5 listed)
- Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
- Potentially curable resection not possible
- Patient undergoing emergency procedure
- Metastatic disease
- Pregnant or suspected pregnancy
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 |
|---|---|---|
| Composite meshPelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation. | Device | Mesh group |
Primary outcome
Comprehensive Complication index
Time frame: 30 days
Comprehensive Complication index is used to evaluate outcome
8 secondary outcomes
Surgical site infection
Time frame: 30 days
Reoperation rate
Time frame: 30 days
Operative time
Time frame: 30 days
Length of stay
Time frame: 30 days
Costs
Time frame: 30 days
Total perineal healing time
Time frame: 30 days
Perineal sinus
Time frame: 30 days
Perineal hernia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elisa Mäkäräinen-Uhlbäck, M.D. principal investigator
Oulu 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 Rectal Cancer and Abdominoperineal Resection, run by Elisa Mäkäräinen at 1 site in Finland.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 1 Feb 2024. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication index (time frame: 30 days). 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 1 Feb 2024.