Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
NCT ID: NCT01117337
Last Updated: 2010-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2008-09-30
2010-05-31
Brief Summary
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1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia
2. To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.
Detailed Description
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Decreased post operative pain and lesser morbidity are the main advantages of Total Extra Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. The disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma formation and difficult learning curve. Fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. This had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair. Requirement of GA for TEP repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We earlier reported that TEP repair could be done without fixation of the mesh under regional anesthesia.
This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. The end points measured would be the recurrence of the hernia and pain in the post operative period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mesh Non Fixation Group
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed by ant means
Mesh Fixation
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Interventions
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Mesh Fixation
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Obstructed and strangulated hernias
* Pediatric hernias
* Associated other hernias like ventral hernias
* Unfit for spinal anesthesia
16 Years
85 Years
ALL
No
Sponsors
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Moulana Hospital
OTHER
Responsible Party
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Moulana Hospital
Principal Investigators
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Mohamed Ismail, MBBS, MS
Role: PRINCIPAL_INVESTIGATOR
Moulana Hospital
Locations
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Moulana Hospital
Perintalmanna, Kerala, India
Countries
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References
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Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
Taylor C, Layani L, Liew V, Ghusn M, Crampton N, White S. Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomised clinical trial. Surg Endosc. 2008 Mar;22(3):757-62. doi: 10.1007/s00464-007-9510-7. Epub 2007 Sep 21.
Ferzli GS, Frezza EE, Pecoraro AM Jr, Ahern KD. Prospective randomized study of stapled versus unstapled mesh in a laparoscopic preperitoneal inguinal hernia repair. J Am Coll Surg. 1999 May;188(5):461-5. doi: 10.1016/s1072-7515(99)00039-3.
Garg P, Nair S, Shereef M, Thakur JD, Nain N, Menon GR, Ismail M. Mesh fixation compared to nonfixation in total extraperitoneal inguinal hernia repair: a randomized controlled trial in a rural center in India. Surg Endosc. 2011 Oct;25(10):3300-6. doi: 10.1007/s00464-011-1708-z. Epub 2011 May 2.
Other Identifiers
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MH-ECN-04-08
Identifier Type: -
Identifier Source: org_study_id