Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias (HSS-AHS)
Primary Purpose
Abdominal Hernia
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
abdominal wall reconstruction
Sponsored by
About this trial
This is an interventional screening trial for Abdominal Hernia focused on measuring position of the mesh, recurrence rate, surgical procedure, long time outcome
Eligibility Criteria
Inclusion Criteria:
- During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
- All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
- For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
Exclusion Criteria:
- Ages fewer than 18 or above 70 years
- Hernia orifice under 5 cm2.
- Planned or accidental intraoperative opening of any bowel.
- Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
- Severe renal or hepatic failure
- Advanced stage of tumours or currently treated malignancies.
- Inflamed or muddy content of hernia sac.
- If the patient did not signed the consent form.
Sites / Locations
- Dept. of Surgery Univ. of Pecs
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
small hernias - suture repair
small hernias - mesh repair
large hernias - sublay mesh
large hernias - onlay mesh
Arm Description
Outcomes
Primary Outcome Measures
recurrence rate after hernia surgery
Secondary Outcome Measures
chronic pain after hernia surgery
complications after hernia surgery
Full Information
NCT ID
NCT01018524
First Posted
October 13, 2009
Last Updated
March 7, 2010
Sponsor
Hungarian Surgical Society
1. Study Identification
Unique Protocol Identification Number
NCT01018524
Brief Title
Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
Acronym
HSS-AHS
Official Title
Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hungarian Surgical Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to:
compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.
Detailed Description
To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hernia
Keywords
position of the mesh, recurrence rate, surgical procedure, long time outcome
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
small hernias - suture repair
Arm Type
Active Comparator
Arm Title
small hernias - mesh repair
Arm Type
Active Comparator
Arm Title
large hernias - sublay mesh
Arm Type
Active Comparator
Arm Title
large hernias - onlay mesh
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
abdominal wall reconstruction
Intervention Description
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
Primary Outcome Measure Information:
Title
recurrence rate after hernia surgery
Time Frame
5 years
Secondary Outcome Measure Information:
Title
chronic pain after hernia surgery
Time Frame
more one year
Title
complications after hernia surgery
Time Frame
0-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
Exclusion Criteria:
Ages fewer than 18 or above 70 years
Hernia orifice under 5 cm2.
Planned or accidental intraoperative opening of any bowel.
Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
Severe renal or hepatic failure
Advanced stage of tumours or currently treated malignancies.
Inflamed or muddy content of hernia sac.
If the patient did not signed the consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
György Wéber, Prof. Dr.
Organizational Affiliation
Hungarian Surgical Society
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
József Baracs, Dr.
Organizational Affiliation
Hungarian Surgical Society
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Surgery Univ. of Pecs
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
12474512
Citation
Weber G, Horvath OP. [Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study]. Magy Seb. 2002 Oct;55(5):285-9. Hungarian.
Results Reference
background
PubMed Identifier
20965863
Citation
Weber G, Baracs J, Horvath OP. ["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up]. Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3. Hungarian.
Results Reference
derived
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Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
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