PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

Study Overview
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Brief Summary
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This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.

Detailed Description
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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.

Official Title
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PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

Conditions
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Rectum Cancer

Intervention / Treatment
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* Device: Parietene Macro
* Device: Permacol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective randomized controlled multicenter trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parietene Macro<br>Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. | Device: Parietene Macro<br>* Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.<br>|
| Active Comparator: Permacol<br>Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. | Device: Permacol<br>* Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | The incidence of surgical site infections at 30 days follow up | 30 days | 
| Incisional hernia | Incidence of incisional hernia | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications classified by Clavien-Dindo classification | Clavien-Dindo I-V complications at 30 days follow-up | 30 days | 
| Re-operation rate | Demand for re-operations related to mesh or complications | 5 years | 
| Operative time | Time (min) needed for operation and application of mesh/implant | 30 days | 
| Length of stay | Length of stay at the hospital after the operation | 30 days | 
| Quality of life measured by RAND-36 survey | Quality of life after the operation measured by RAND 36 | 5 years | 
| Incidence of hernia | Incidence of incisional hernia | 5 years | 
| Cost analysis | Analysis of costs to both individual and community | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loop-ileostomy reversal, hernia prevention