APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
NCT ID: NCT04334421
Last Updated: 2024-02-01
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2020-04-03
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Previous studies on synthetic mesh repair on perineum are almost lacking.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pelvic Floor Reconstruction Using Biological Mesh With Negative Pressure Wound Therapy Following ELAPE
NCT04033484
Wound Healing After Emergency Appendicectomy
NCT00913445
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
NCT00902148
Optimal Care of Complicated Appendicitis
NCT03159754
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
NCT00512356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mesh group
After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.
Composite mesh
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Composite mesh
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Potentially curable resection not possible
* Patient undergoing emergency procedure
* Metastatic disease
* Pregnant or suspected pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elisa Mäkäräinen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elisa Mäkäräinen
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elisa Mäkäräinen-Uhlbäck, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oulu University Hospital
Oulu, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
57/2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.