APEMESH II - Perineal Reconstruction

Rectal Cancer Clinical Trial

Official title:

Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779125
• Other study ID #: 115/2020
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: January 2024
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Description:

Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Curative intent abdominoperineal resection and permanent colostomy

Exclusion Criteria:

• Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)

• Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)

• Diabetes with 1 or more organ damage

• Dialysis treatment

• Hepatic cirrhosis Child-Bugh B-C

• Potentially curable resection not possible

• Patient undergoing emergency procedures

• Metastatic disease

• Vaginal resection, pelvic exenteration and sacrum resection

• Vaginal perforation

• Pelvic abscess or perforated tumor

• Pregnant or suspected pregnancy

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Gluteus plasty enhanced with Progrip self gripping mesh
Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Comprehensive complication index	30 days
Secondary	Surgical site infections	Surgical site infections	30 days
Secondary	Reoperation rate	Reoperation rate	30 days
Secondary	Operative time	Operative time to reconstruct perineum	30 days
Secondary	Length of hospital stay	Primary length of stay at the hospital	30 days
Secondary	Costs of treatment materials	Costs of treatment materials	30 days
Secondary	Total perineal healing time	Time from operation to complete perineal healing	1 year
Secondary	Perineal fistula	Perineal sinus or fistula	30 days
Secondary	Perineal hernia	Perineal hernia incidence	12 months
Secondary	Gluteus muscle function measured by time stands test	Gluteus muscle function measured by time stands test	12 months