APEMESH II - Perineal Reconstruction

Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Gluteus plasty enhanced with Progrip self gripping mesh

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa Mäkäräinen-Uhlbäck, M.D.; Phone Number: +35883152282; Email: elisa.makarainen-uhlback@ppshp.fi
• Study Contact Backup: Name: Katariina Kilpivaara, M.D.; Phone Number: +35883152011; Email: katariina.kilpivaara@ppshp.fi

Study Locations

• Finland
  • Oulu, Finland
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gluteus plasty enhanced with Progrip self gripping mesh; All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Comprehensive complication index	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Study Chair: Tero Rautio, M.D. Ph.D., Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: abdominoperineal resection; perineal reconstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 115/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No