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| ID | Type | Description | Link |
|---|---|---|---|
| REC REF 2009-080 |
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| Name | Class |
|---|---|
| Mulago Hospital, Uganda | OTHER |
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The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.
The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-mesh Hernia Repair | Experimental | Reinforcement with a strip of external oblique aponeurosis |
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| Mesh Hernia Repair | Active Comparator | Polypropylene mesh placement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-mesh Hernia Repair | Procedure | Non-mesh method for treatment of inguinal hernia without the use of a foreign material (mesh). It involves reinforcement of the weakened posterior wall of inguinal canal with a small, undetached strip of aponeurotic tissue of external |
| Measure | Description | Time Frame |
|---|---|---|
| Acute groin pain after surgery (measured on pain visual analogue scale of 0-10) | 2 Weeks | |
| Time (in days) taken to return to normal gait | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time (in Minutes) | 2 hours | |
| Complications during and after surgery | 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Manyilirah | Makerere University | Principal Investigator |
| Alex Upoki | Makerere University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago National Referral Hospital | Kampala | Central Region | Uganda |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 2, 2009 | |
| Reset | Dec 1, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2009 | Dec 1, 2009 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mesh Hernia Repair | Procedure | Mesh method for treatment of inguinal hernias by use of an implant (mesh) to reinforce the weakened posterior wall of the inguinal canal. The mesh is made of polypropylene material. |
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