The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment. (DESLICH)
Primary Purpose
Hernia, Inguinal
Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Desarda technique
Lichtenstein technique
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring inguinal hernia, hernia recurrence, no mesh techniques, Desarda technique
Eligibility Criteria
Inclusion Criteria:
- primary inguinal hernia
- male adults
- signed informed consent
- god condition of external oblique aponeurosis (assessed during the operation)
Exclusion Criteria:
- age < 18
- recurrent hernia
- incarcerated hernia
- diagnosed mental disorder
- manual reduction of hernia on inpatient
- infection at groin area
- wound or scar at the groin
- no consent
Sites / Locations
- Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Desarda group
Lichtenstein group
Arm Description
Patients with primary inguinal hernia operated using the Desarda technique
Patients with primary inguinal hernia operated using the Lichtenstein technique.
Outcomes
Primary Outcome Measures
recurrence
hernia recurrence after surgical treatement
chronic pain
persistent chronic pain (lasting longer then 6 months)
Secondary Outcome Measures
surgical complications
edema, hematoma, ecchymosis, infaction of the wound
Full Information
NCT ID
NCT01237470
First Posted
November 8, 2010
Last Updated
November 8, 2010
Sponsor
Nicolaus Copernicus University
1. Study Identification
Unique Protocol Identification Number
NCT01237470
Brief Title
The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.
Acronym
DESLICH
Official Title
The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
protocol completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nicolaus Copernicus University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.
Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.
The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.
To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.
Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
inguinal hernia, hernia recurrence, no mesh techniques, Desarda technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2009 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desarda group
Arm Type
Experimental
Arm Description
Patients with primary inguinal hernia operated using the Desarda technique
Arm Title
Lichtenstein group
Arm Type
Experimental
Arm Description
Patients with primary inguinal hernia operated using the Lichtenstein technique.
Intervention Type
Procedure
Intervention Name(s)
Desarda technique
Intervention Description
no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein technique
Other Intervention Name(s)
open plain mesh technique
Intervention Description
hernioplasty with the usage of plain polypropylene mesh
Primary Outcome Measure Information:
Title
recurrence
Description
hernia recurrence after surgical treatement
Time Frame
3 years
Title
chronic pain
Description
persistent chronic pain (lasting longer then 6 months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
surgical complications
Description
edema, hematoma, ecchymosis, infaction of the wound
Time Frame
3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary inguinal hernia
male adults
signed informed consent
god condition of external oblique aponeurosis (assessed during the operation)
Exclusion Criteria:
age < 18
recurrent hernia
incarcerated hernia
diagnosed mental disorder
manual reduction of hernia on inpatient
infection at groin area
wound or scar at the groin
no consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw Dabrowiecki, MD, PhD
Organizational Affiliation
Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
11471669
Citation
Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. doi: 10.1080/110241501750243798.
Results Reference
background
PubMed Identifier
12697071
Citation
Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. doi: 10.1186/1471-2482-3-2.
Results Reference
background
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The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.
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