Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
Primary Purpose
Parastomal Hernia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Sponsored by
About this trial
This is an interventional prevention trial for Parastomal Hernia focused on measuring Parastomal, hernia
Eligibility Criteria
Inclusion Criteria:
- Patients with permanent ostomy and 1 years of life expectancy
- Signed informed consent
Exclusion Criteria:
- Allergy to the compounds of the mesh
- Rejection of the patient
- Rejection of the surgeon
- Field of emergency
- Life expectancy < 1 year
- Prior meshes in the surgical site
Sites / Locations
- Hospital Universitari Valldhebron Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prophylactic mesh
without prophylactic mesh
Arm Description
All patients will have a permanent ostomy and a randomisation with prophylactic mesh
All patients will have a permanent ostomy and a randomisation without prophylactic mesh
Outcomes
Primary Outcome Measures
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Secondary Outcome Measures
Measuring the quality of life using the SF-36
Full Information
NCT ID
NCT00908661
First Posted
May 25, 2009
Last Updated
March 23, 2017
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00908661
Brief Title
Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
Official Title
Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.
Detailed Description
Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.
Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia
Keywords
Parastomal, hernia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic mesh
Arm Type
Active Comparator
Arm Description
All patients will have a permanent ostomy and a randomisation with prophylactic mesh
Arm Title
without prophylactic mesh
Arm Type
No Intervention
Arm Description
All patients will have a permanent ostomy and a randomisation without prophylactic mesh
Intervention Type
Device
Intervention Name(s)
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Other Intervention Name(s)
PROCEED mesh
Intervention Description
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Primary Outcome Measure Information:
Title
If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Time Frame
24 to 36 months after surgery
Secondary Outcome Measure Information:
Title
Measuring the quality of life using the SF-36
Time Frame
Preoperative and at the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with permanent ostomy and 1 years of life expectancy
Signed informed consent
Exclusion Criteria:
Allergy to the compounds of the mesh
Rejection of the patient
Rejection of the surgeon
Field of emergency
Life expectancy < 1 year
Prior meshes in the surgical site
Facility Information:
Facility Name
Hospital Universitari Valldhebron Research Institute
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
19300232
Citation
Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.
Results Reference
background
PubMed Identifier
19502871
Citation
Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.
Results Reference
background
PubMed Identifier
22782367
Citation
Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.
Results Reference
derived
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Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
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