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

This study has been completed.
Sponsor:
Information provided by:
Moulana Hospital
ClinicalTrials.gov Identifier:
NCT01117337
First received: May 3, 2010
Last updated: August 9, 2010
Last verified: July 2008
  Purpose

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.

Condition Intervention Phase
Inguinal Hernia
Procedure: Mesh Fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair Under Spinal Anesthesia- A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Moulana Hospital:

Primary Outcome Measures:
  • Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Proportion of Patients Having Pain in the Post Operative Period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.


Secondary Outcome Measures:
  • Seroma Formation [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mesh fixation by Tacker

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

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117337

Locations
India
Moulana Hospital
Perintalmanna, Kerala, India, 679322
Sponsors and Collaborators
Moulana Hospital
Investigators
Principal Investigator: Mohamed Ismail, MBBS, MS Moulana Hospital
  More Information

Publications:
Responsible Party: Mohamed Ismail, Moulana Hospital
ClinicalTrials.gov Identifier: NCT01117337     History of Changes
Other Study ID Numbers: MH-ECN-04-08
Study First Received: May 3, 2010
Results First Received: July 7, 2010
Last Updated: August 9, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Moulana Hospital:
Hernia, laparoscopic, recurrence, pain, inguinal

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014