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

Tracking Information

• First Submitted Date: February 7, 2018
• First Posted Date: February 26, 2018
• Last Update Posted Date: February 1, 2024
• Actual Study Start Date: February 13, 2018
• Actual Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 19, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 10, 2018)

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

Original Secondary Outcome Measures (submitted: February 19, 2018)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
• Official Title: PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Rectum Cancer

Intervention

• 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.

Study Arms

• 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.
  Intervention: Device: Parietene Macro
• Active Comparator: Permacol
  Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
  Intervention: Device: Permacol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 19, 2018): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2027
• Actual Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT03445936
• Other Study ID Numbers: 317/2017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Elisa Mäkäräinen, University of Oulu
• Original Responsible Party: Elisa Makarainen-Uhlback, University of Oulu, MD
• Current Study Sponsor: University of Oulu
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Oulu
• Verification Date: January 2024