search
Back to results

APEMESH II - Perineal Reconstruction

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Gluteus plasty enhanced with Progrip self gripping mesh
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring abdominoperineal resection, perineal reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gluteus plasty enhanced with Progrip self gripping mesh

Arm Description

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

Outcomes

Primary Outcome Measures

Complications
Comprehensive complication index

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2021
Last Updated
May 4, 2021
Sponsor
University of Oulu
search

1. Study Identification

Unique Protocol Identification Number
NCT04779125
Brief Title
APEMESH II - Perineal Reconstruction
Official Title
Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
abdominoperineal resection, perineal reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gluteus plasty enhanced with Progrip self gripping mesh
Arm Type
Experimental
Arm Description
All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Gluteus plasty enhanced with Progrip self gripping mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complications
Description
Comprehensive complication index
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical site infections
Description
Surgical site infections
Time Frame
30 days
Title
Reoperation rate
Description
Reoperation rate
Time Frame
30 days
Title
Operative time
Description
Operative time to reconstruct perineum
Time Frame
30 days
Title
Length of hospital stay
Description
Primary length of stay at the hospital
Time Frame
30 days
Title
Costs of treatment materials
Description
Costs of treatment materials
Time Frame
30 days
Title
Total perineal healing time
Description
Time from operation to complete perineal healing
Time Frame
1 year
Title
Perineal fistula
Description
Perineal sinus or fistula
Time Frame
30 days
Title
Perineal hernia
Description
Perineal hernia incidence
Time Frame
12 months
Title
Gluteus muscle function measured by time stands test
Description
Gluteus muscle function measured by time stands test
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa Mäkäräinen-Uhlbäck, M.D.
Phone
+35883152282
Email
elisa.makarainen-uhlback@ppshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Katariina Kilpivaara, M.D.
Phone
+35883152011
Email
katariina.kilpivaara@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tero Rautio, M.D. Ph.D.
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Mäkäräinen-Uhlbäck, M.D.
Phone
+35883152282
Email
elisa.makarainen-uhlback@ppshp.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

APEMESH II - Perineal Reconstruction

We'll reach out to this number within 24 hrs