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

• ClinicalTrials.gov Identifier: NCT03445936
• Recruitment Status: Active, not recruiting
• First Posted: February 26, 2018
• Last Update Posted: February 1, 2024
• Sponsor: University of Oulu
• Information provided by (Responsible Party): Elisa Mäkäräinen, University of Oulu

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rectum Cancer	Device: Parietene Macro; Device: Permacol	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a prospective randomized controlled multicenter trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
• Primary Purpose: Prevention
• Official Title: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
• Actual Study Start Date: February 13, 2018
• Actual Primary Completion Date: October 30, 2022
• Estimated Study Completion Date: October 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Surgical site infection [ Time Frame: 30 days ]
   The incidence of surgical site infections at 30 days follow up
2. Incisional hernia [ Time Frame: 10 months ]
   Incidence of incisional hernia

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Finland

Jyvaskyla Central Hospital

Jyvaskyla, Finland

Oulu University Hospital

Oulu, Finland

Seinajoki Central Hospital

Seinäjoki, Finland

Tampere University Hospital

Tampere, Finland

Sponsors and Collaborators

University of Oulu

Investigators

• Principal Investigator: Elisa Mäkäräinen-Uhlbäck; Oulu University Hospital

More Information

• Responsible Party: Elisa Mäkäräinen, MD, University of Oulu
• ClinicalTrials.gov Identifier: NCT03445936
• Other Study ID Numbers: 317/2017
• First Posted: February 26, 2018
• Last Update Posted: February 1, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elisa Mäkäräinen, University of Oulu:

loop-ileostomy reversal; hernia prevention

Additional relevant MeSH terms:

Rectal Neoplasms; Hernia; Incisional Hernia; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases