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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2027-10-31

Brief Summary

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

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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.

Conditions

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Rectum Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective randomized controlled multicenter trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.

Study Groups

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Parietene Macro

Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Group Type ACTIVE_COMPARATOR

Parietene Macro

Intervention Type DEVICE

Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Permacol

Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Group Type ACTIVE_COMPARATOR

Permacol

Intervention Type DEVICE

Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Interventions

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Parietene Macro

Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Intervention Type DEVICE

Permacol

Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No