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OpenTrials
Completed

NCT Number: NCT00509054

Prevention of Parastomal Hernia With a Mesh

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.

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Key information

Conditions

Parastomal Hernia Infections Wound Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kirurgkliniken Sundsvalls sjukhus

Sundsvall, SE-85186, Sweden

About this study

Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.

A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.

Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.

Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical need of an enterostoma

Exclusion criteria

  • Patients denies inclusion in the trial.

Treatment and study plan

Prophylactic mesh

Procedure

A low weigth partly absorbable mesh in a subaly posistion

Other names: Vypro mesh, Ethicon.

Primary outcomes

  1. Wound infection,mesh infection, parastomal hernia.

    Time frame: Within five years

Secondary outcomes

  1. Fistula formation, stenosis,pain.

    Time frame: Within five years

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Registry information

Official study title

Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Jul 31, 2007
Registry last updated
Apr 16, 2008

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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