Back to resultsHernia Prevention in Stomas
Primary Purpose
Incisional Hernia, Parastomal Hernia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Parietex Parastomal Mesh
Sponsored by
About this trial
This is an interventional prevention trial for Incisional Hernia focused on measuring stoma
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mesh placement
Arm Description
Outcomes
Primary Outcome Measures
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
incisional herniation at the old stoma wound
Secondary Outcome Measures
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00907842
Brief Title
Hernia Prevention in Stomas
Official Title
Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Schreinemacher
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Parastomal Hernia
Keywords
stoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mesh placement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Parietex Parastomal Mesh
Intervention Description
mesh placed intraperitoneally around the stoma
Primary Outcome Measure Information:
Title
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
Time Frame
one year after placement
Title
incisional herniation at the old stoma wound
Time Frame
two years
Secondary Outcome Measure Information:
Title
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Time Frame
two years after placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Bouvy, MD, PhD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marc Schreinemacher, MD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6200 AZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19011935
Citation
Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
Results Reference
background
PubMed Identifier
17120189
Citation
Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4.
Results Reference
background
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Hernia Prevention in Stomas
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