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

U

University of Oulu

Status

Active, not recruiting

Conditions

Rectum Cancer

Treatments

Device: Permacol
Device: Parietene Macro

Study type

Interventional

Funder types

Other

Identifiers

NCT03445936
317/2017

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Parietene Macro
Active Comparator group
Description:
Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Treatment:
Device: Parietene Macro
Permacol
Active Comparator group
Description:
Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Treatment:
Device: Permacol

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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