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A randomised controlled study to compare the use of Permacol™ for repair of parastomal hernias with current treatment with either synthetic mesh or primary suture repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79431254
Enrollment
Unknown
Registered
2004-09-21
Start date
2004-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastonal hernia Surgery Parastomal hernia

Interventions

There is no standard method to repair parastomal hernias. Some surgeons use primary repair which involves suturing the patient's tissue directly with suture material, whereas others prefer to use a su

Sponsors

Tissue Science Laboratories plc (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients must have a symptomatic parastomal hernia; be aged over 18 (or the country applicable age of consent); if of child-bearing age must have given a negative pregnancy test; give written informed consent; agree to be randomised.

Exclusion criteria

Exclusion criteria: Patients must not be taking part in another clinical study; not be suffering from an UNTREATED metabolic or systemic illness (e.g. diabetes or rheumatoid arthritis); not have a diagnosis of mentally limiting conditions such as Alzheimer's or mental retardation or be unable to understand all study requirements; not be allergic to any porcine or collagen products.

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026