Hernia Prevention in Stomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-04-30

Brief Summary

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Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

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Detailed Description

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The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.

Conditions

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Incisional Hernia Parastomal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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mesh placement

Group Type EXPERIMENTAL

Parietex Parastomal Mesh

Intervention Type DEVICE

mesh placed intraperitoneally around the stoma

Interventions

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Parietex Parastomal Mesh

mesh placed intraperitoneally around the stoma

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients with a life expectancy of at least one year
* Temporary stoma formation
* Signed informed consent
* Elective surgery
* Clean-contaminated abdomen

Exclusion Criteria

* American Society of Anaesthesiologists (ASA) score IV or above
* Incapacitated adult or no signed informed consent
* Emergency procedure
* Contaminated or infected abdomen
* Residual intraperitoneal mesh
* Already injured part of the abdominal wall where the stoma will be sited
* Contraindication to laparoscopy
* Longterm use of corticosteroids and other immunosuppressive agents
* Current antibiotic therapy
* One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No