Prevention of Parastomal Hernia With a Mesh

Sundsvall Hospital54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Parastomal Hernia

Interventions

Prophylactic meshPROCEDURE

A low weigth partly absorbable mesh in a subaly posistion

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical need of an enterostoma Exclusion Criteria: * Patients denies inclusion in the trial.

Locations (1)

Kirurgkliniken Sundsvalls sjukhus

Sundsvall, Sweden

Outcomes

Primary Outcomes

Wound infection,mesh infection, parastomal hernia.

Time frame: Within five years

Secondary Outcomes

Fistula formation, stenosis,pain.

Time frame: Within five years

Data from ClinicalTrials.gov

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