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

NCT03445936 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-01

No results posted yet for this study

Summary

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

Conditions

  • Rectum Cancer

Interventions

DEVICE

Parietene Macro

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

DEVICE

Permacol

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

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Elisa Mäkäräinen-Uhlbäck · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2022-10-30
Completion
2027-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445936 on ClinicalTrials.gov