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NCT Number: NCT03445936

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jyvaskyla Central Hospital, Jyväskylä, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parietene Macro

Device

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

Permacol

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Feb 26, 2018
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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