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Spots Global Cancer Trial Database for APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

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Trial Identification

Brief Title: APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Official Title: APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Study ID: NCT04334421

Interventions

Composite mesh

Study Description

Brief 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. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Oulu University Hospital, Oulu, , Finland

Contact Details

Name: Elisa Mäkäräinen-Uhlbäck, M.D.

Affiliation: Oulu University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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