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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Oulu University Hospital
Oulu, Finland
Start Date
April 3, 2020
Primary Completion Date
February 28, 2021
Completion Date
February 28, 2022
Last Updated
February 1, 2024
30
ACTUAL participants
Composite mesh
DEVICE
Lead Sponsor
Elisa Mäkäräinen
NCT04704661
NCT04929028
Data Source & Attribution
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