Hernia, Inguinal
Conditions
Keywords
Inguinal, Hernia, Hernia-repair, Non-mesh, Mesh, Desarda, Lichtenstein
Brief summary
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.
Interventions
PROCEDURENon-mesh Hernia Repair
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
PROCEDUREMesh Hernia Repair
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.
Sponsors
Mulago Hospital, Uganda
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 and above; * with a primary, reducible inguinal or inguino-scrotal hernia; * who consent to participate in the study; * who have a telephone contact.
Exclusion criteria
* Giant inguino-scrotal hernias; * Obstructive uropathy or chronic obstructive pulmonary disease; * Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Operative time (in Minutes) | 2 hours |
| Complications during and after surgery | 2 Weeks |
Countries
Uganda
Outcome results
None listed