Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair Under Spinal Anesthesia- A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117337
• Other study ID #: MH-ECN-04-08
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: August 9, 2010
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2008
• Source: Moulana Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Mesh Fixation
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure

Locations

Country	Name	City	State
India	Moulana Hospital	Perintalmanna	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Moulana Hospital

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View 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. — View 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. Epub 2007 Sep 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.	Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.	1 year	No
Primary	Proportion of Patients Having Pain in the Post Operative Period	To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.	1 month	No
Secondary	Seroma Formation	A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.	One year	No