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

Not Applicable

Active, not recruiting

• Conditions: Rectum Cancer
• Interventions: Device: Permacol; Device: Parietene Macro

• Registration Number: NCT03445936
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2018-02-07
• Study Start: 2018-02-13
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Primary Completion: 2022-10-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Permacol	Permacol	Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Parietene Macro	Parietene Macro	Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.

Primary Outcome Measures

Name	Time	Method
Incisional hernia	10 months	Incidence of incisional hernia
Surgical site infection	30 days	The incidence of surgical site infections at 30 days follow up

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Seinajoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Jyvaskyla Central Hospital; 🇫🇮 Jyvaskyla, Finland