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Completed

NCT Number: NCT02121743

Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

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Key information

Conditions

Parastomal Hernia Terminal Colostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens Universitary Hospital, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient requiring a colorectal surgery with a terminal colostomy
  • Elective or emergency surgery

Exclusion criteria

  • Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
  • Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
  • Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
  • Is pregnant, or lactating.
  • Allergic to any porcine or collagen products.
  • survival < 6 months

Treatment and study plan

Strattice

Device

use of a strattice

No strattice

Procedure

no use of a strattice

Primary outcomes

  1. rate of parastomal hernia

    Time frame: postoperative month 6

    the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan

Secondary outcomes

  1. evaluation of the pain

    Time frame: 2 years after the surgery

    The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery

  2. the postoperative morbidity

    Time frame: postoperative month 1

    the postoperative morbidity will be assessed with the Dindo Clavien classification

  3. the parastomal hernia rate

    Time frame: postoperative year 1

    The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination

  4. the quality of life

    Time frame: 2 years after the surgery

    The quality of life will be assessed with the STOMA QoL form, the 12-Item Short Form Health Survey (SF12) and the Carolina comfort scale at 1 month, 6 months, 1 year and 2 years after the surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • LifeCell

Registry information

Official study title

Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

Acronym: PROBIOCOL

Important dates

Study start
2014
Primary completion
2024
Study completion
2025
First posted
Apr 23, 2014
Registry last updated
Jun 12, 2026

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

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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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