Clinical trial NCT01117337: Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair
Official title: Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair Under Spinal Anesthesia- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: Hernia, laparoscopic, recurrence, pain, inguinal
Lead sponsor: Moulana Hospital
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 104
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is

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: Hernia repair is one of the most common surgery performed all over the world. The same is true about India. With more than a billion population, the number of hernia patients in India perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India.

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.

Eligibility criteria: Inclusion Criteria:

* All reducible inguinal hernias will be included in the study

Exclusion Criteria:

* Irreducible hernia after anesthesia
* Obstructed and strangulated hernias
* Pediatric hernias
* Associated other hernias like ventral hernias
* Unfit for spinal anesthesia

Primary outcomes:
measure: Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.
timeFrame: 1 year
measure: Proportion of Patients Having Pain in the Post Operative Period
timeFrame: 1 month
Secondary outcomes:
measure: Seroma Formation
timeFrame: One year
Other outcomes:
Locations:
city: Perintalmanna
country: India
facility: Moulana Hospital
state: Kerala
Study officials:
affiliation: Moulana Hospital
name: Mohamed Ismail, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.