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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rectum Cancer
• Intervention / Treatment: Device: Parietene Macro; Device: Permacol

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Jyvaskyla, Finland
    • Jyväskylä Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Seinäjoki, Finland
    • Seinäjoki Central Hospital
  • Tampere, Finland
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Principal Investigator: Elisa Mäkäräinen-Uhlbäck, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): October 30, 2022
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hernia prevention; loop-ileostomy reversal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Hernia; Rectal Neoplasms; Incisional Hernia
• Other Study ID Numbers: 317/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No