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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04334421
Other study ID # 57/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 3, 2020
Est. completion date February 28, 2022

Study information

Verified date January 2024
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 28, 2022
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Abdominoperineal resection and permanent colostoma Exclusion Criteria: - 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

Study Design


Intervention

Device:
Composite mesh
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.

Locations

Country Name City State
Finland Oulu University Hospital Oulu

Sponsors (1)

Lead Sponsor Collaborator
Elisa Mäkäräinen

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comprehensive Complication index Comprehensive Complication index is used to evaluate outcome 30 days
Secondary Surgical site infection Surgical site infection classified by Clavien-Dindo score 30 days
Secondary Reoperation rate Reoperations during primary stay at the hospital 30 days
Secondary Operative time Operative time 30 days
Secondary Length of stay Length of stay at the hospital during primary operation and recovery 30 days
Secondary Costs Costs by materials used 30 days
Secondary Total perineal healing time Time to point when perineum is closed and healed 30 days
Secondary Perineal sinus Presence of perineal sinus at 30 days follow-up 30 days
Secondary Perineal hernia Perineal hernia by CT scan at 12 months follow-up 12 months
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