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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117337
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : August 31, 2010
Last Update Posted : August 31, 2010
Information provided by:
Moulana Hospital

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Mesh Fixation Phase 4

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  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Hernia
U.S. FDA Resources

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 Name: Mesh fixation by Tacker

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117337

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mohamed Ismail, Moulana Hospital Identifier: NCT01117337     History of Changes
Other Study ID Numbers: MH-ECN-04-08
First Posted: May 5, 2010    Key Record Dates
Results First Posted: August 31, 2010
Last Update Posted: August 31, 2010
Last Verified: July 2008

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

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal