APEMESH II - Perineal Reconstruction

NCT04779125 | Completed

• 1 other identifier: 115/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

abdominoperineal resection; perineal reconstruction

Outcome Measures

Primary Outcomes (1)

• Complications

  Comprehensive complication index

  30 days

Secondary Outcomes (9)

• Surgical site infections

  30 days

• Reoperation rate

  30 days

• Operative time

  30 days

• Length of hospital stay

  30 days

• Costs of treatment materials

  30 days

Study Arms (1)

Gluteus plasty enhanced with Progrip self gripping mesh

EXPERIMENTAL

All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction.

Procedure: Gluteus plasty enhanced with Progrip self gripping mesh

Interventions

Gluteus plasty enhanced with Progrip self gripping mesh PROCEDURE

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.

Gluteus plasty enhanced with Progrip self gripping mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Curative intent abdominoperineal resection and permanent colostomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tero Rautio, M.D. Ph.D.

  Oulu University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 3, 2021
• Study Start: March 19, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)