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protocol completed
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desarda group | Experimental | Patients with primary inguinal hernia operated using the Desarda technique |
|
| Lichtenstein group | Experimental | Patients with primary inguinal hernia operated using the Lichtenstein technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desarda technique | Procedure | no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence | hernia recurrence after surgical treatement | 3 years |
| chronic pain | persistent chronic pain (lasting longer then 6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| surgical complications | edema, hematoma, ecchymosis, infaction of the wound | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislaw Dabrowiecki, MD, PhD | Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University | Bydgoszcz | 85-094 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11471669 | Background | 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. | |
| 12697071 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 1, 2014 | |
| Reset | May 1, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 1, 2014 | May 1, 2014 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lichtenstein technique | Procedure | hernioplasty with the usage of plain polypropylene mesh |
|
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