APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Rectal Cancer Clinical Trial

Official title:

APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334421
• Other study ID #: 57/2020
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Abdominoperineal Resection
• Rectal Cancer
• Rectal Neoplasms
• Wound Heal

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