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

August 9, 2010 updated by: Moulana Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Perintalmanna, Kerala, India, 679322
        • Moulana Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Mesh Non Fixation Group
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed by ant means
Procedure: Mesh Fixation
Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
Other Names:
  • Mesh fixation by Tacker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.
Time Frame: 1 year
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
Proportion of Patients Having Pain in the Post Operative Period
Time Frame: 1 month
To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroma Formation
Time Frame: One year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moulana Hospital

Investigators

  • Principal Investigator: Mohamed Ismail, MBBS, MS, Moulana Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH-ECN-04-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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