Back to resultsPRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Primary Purpose
Rectum Cancer
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Parietene Macro
Permacol
Sponsored by
About this trial
This is an interventional prevention trial for Rectum Cancer focused on measuring loop-ileostomy reversal, hernia prevention
Eligibility Criteria
Inclusion Criteria:
- Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
- 18 years or older
- Patient has a life expectancy of at least 12 months.
- Patient signs the Informed consent and agrees to attend all study visits
Exclusion Criteria:
- Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
- Patients with concurrent or previous malignant tumors within 5 years before study enrollment
- Patients with T4b tumors which imposed a multi-organ resection
- Patient undergone emergency procedures
- Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- Metastatic disease with life expectancy of less than 12 months
- Pregnancy or suspected pregnancy
Sites / Locations
- Jyvaskyla Central Hospital
- Oulu University Hospital
- Seinajoki Central Hospital
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Parietene Macro
Permacol
Arm Description
Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Outcomes
Primary Outcome Measures
Surgical site infection
The incidence of surgical site infections at 30 days follow up
Incisional hernia
Incidence of incisional hernia
Secondary Outcome Measures
Complications classified by Clavien-Dindo classification
Clavien-Dindo I-V complications at 30 days follow-up
Re-operation rate
Demand for re-operations related to mesh or complications
Operative time
Time (min) needed for operation and application of mesh/implant
Length of stay
Length of stay at the hospital after the operation
Quality of life measured by RAND-36 survey
Quality of life after the operation measured by RAND 36
Incidence of hernia
Incidence of incisional hernia
Cost analysis
Analysis of costs to both individual and community
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03445936
Brief Title
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Official Title
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2027 (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
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Detailed Description
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
Keywords
loop-ileostomy reversal, hernia prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective randomized controlled multicenter trial
Masking
ParticipantOutcomes Assessor
Masking Description
Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parietene Macro
Arm Type
Active Comparator
Arm Description
Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Arm Title
Permacol
Arm Type
Active Comparator
Arm Description
Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Intervention Type
Device
Intervention Name(s)
Parietene Macro
Intervention Description
Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
Intervention Type
Device
Intervention Name(s)
Permacol
Intervention Description
Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
Primary Outcome Measure Information:
Title
Surgical site infection
Description
The incidence of surgical site infections at 30 days follow up
Time Frame
30 days
Title
Incisional hernia
Description
Incidence of incisional hernia
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Complications classified by Clavien-Dindo classification
Description
Clavien-Dindo I-V complications at 30 days follow-up
Time Frame
30 days
Title
Re-operation rate
Description
Demand for re-operations related to mesh or complications
Time Frame
5 years
Title
Operative time
Description
Time (min) needed for operation and application of mesh/implant
Time Frame
30 days
Title
Length of stay
Description
Length of stay at the hospital after the operation
Time Frame
30 days
Title
Quality of life measured by RAND-36 survey
Description
Quality of life after the operation measured by RAND 36
Time Frame
5 years
Title
Incidence of hernia
Description
Incidence of incisional hernia
Time Frame
5 years
Title
Cost analysis
Description
Analysis of costs to both individual and community
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
18 years or older
Patient has a life expectancy of at least 12 months.
Patient signs the Informed consent and agrees to attend all study visits
Exclusion Criteria:
Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
Patients with concurrent or previous malignant tumors within 5 years before study enrollment
Patients with T4b tumors which imposed a multi-organ resection
Patient undergone emergency procedures
Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
Metastatic disease with life expectancy of less than 12 months
Pregnancy or suspected pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Mäkäräinen-Uhlbäck
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jyvaskyla Central Hospital
City
Jyvaskyla
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinajoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
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