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Laparoscopic Inguinal Hernia Repair- Transabdominal Preperitoneal (TAPP) Versus Totally Extra Peritoneal (TEP)

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ClinicalTrials.gov Identifier: NCT00687375
Recruitment Status : Unknown
Verified May 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : May 30, 2008
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

Laparoscopic inguinal hernia repair (LIHR) has got comparable results in comparison to open hernia repair (OHR). Many studies have shown that LIHR gives similar results in terms of recurrence as compared with OHR but with the added advantage of less chances of post operative, pain, wound infection and early return to activity. LIHR was started using the transabdominal preperitoneal (TAPP) approach. Another technique of LIHR that has evolved is totally extra peritoneal (TEP) repair. There is only one study of 52 patients comparing TAPP with TEP repair and thus there is insufficient information as to which of the 2 techniques is better. Therefore, we have designed the present study to compare the transabdominal preperitoneal (TAPP) technique with totally extra peritoneal (TEP) technique of laparoscopic inguinal hernia repair. The advantages of TEP may include - no breach of peritoneum so less risk of bowel injury and post-operative adhesions. We will be using a modified technique of TEP repair where we will not use tacker to fix the mesh to reduce the cost of the procedure. On the other hand, TAPP is easy to perform and probably better for irreducible hernia. There is no such comparative study reported in the literature. We have been performing both TAPP and TEP procedures for hernia repair regularly in the department.

RESEARCH HYPOTHESIS: TEP repair of inguinal hernia is better than TAPP repair in terms of reduced cost and avoidance of peritoneal incision.

OBJECTIVE: To compare the Transabdominal preperitoneal (TAPP) vs. Totally extra peritoneal (TEP) techniques of laparoscopic inguinal hernia repair.


Condition or disease Intervention/treatment
Laparoscopic Inguinal Hernia Repair Procedure: Laparoscopic Inguinal Hernia Repair

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Laparoscopic Inguinal Hernia Repair- Transabdominal Preperitoneal (TAPP) Versus Totally Extra Peritoneal (TEP) Approach
Study Start Date : April 2007
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1
Laparoscopic Inguinal Hernia Repair- Transabdominal preperitoneal (TAPP) approach
Procedure: Laparoscopic Inguinal Hernia Repair
Laparoscopic Inguinal Hernia Repair using Transabdominal preperitoneal (TAPP) Approach
Other Name: TAPP
2
Laparoscopic Inguinal Hernia Repair- Totally extra peritoneal (TEP) Approach
Procedure: Laparoscopic Inguinal Hernia Repair
Laparoscopic Inguinal Hernia Repair using totally extra peritoneal (TEP) Approach
Other Name: TEP


Outcome Measures

Primary Outcome Measures :
  1. Operating time (in minutes) [ Time Frame: Two years ]
  2. Cost of the procedure [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Conversion rate [ Time Frame: Two years ]
  2. Recurrence of hernia [ Time Frame: Two years ]
  3. Major complications [ Time Frame: Two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All consecutive patients with uncomplicated symptomatic inguinal hernia attending the out patient department of surgery at AIIMS will be included in the study.
  • The diagnosis of inguinal hernia will be made clinically.

Exclusion Criteria:

  • Co-morbid conditions making the patients unfit for general anaesthesia
  • Complicated hernia.
  • Uncorrectable coagulopathy
  • Morbid obesity (Body Mass Index > 30)
  • Suspected intra-abdominal or pelvic malignancy.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00687375


Contacts
Contact: Subodh Kumar, MBBS, MS 91-11-2659-4776 subodh6@yahoo.com

Locations
India
All India Institute of Medical Sciences, New Delhi Recruiting
New Delhi, Delhi, India, 110029
Contact: Subodh Kumar, MBBS, MS    91-11-2659-4667    subodh6@yahoo.com   
Principal Investigator: Subodh Kumar, MBBS, MS         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Subodh Kumar, MBBS, MS All India Institute of Medical Sciences, New Delhi-29, India
More Information

Responsible Party: Dr. Subodh Kumar, All India Institute of Medical Sciences, New Delhi-29, India
ClinicalTrials.gov Identifier: NCT00687375     History of Changes
Other Study ID Numbers: A-24/2006
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Inguinal
Groin hernia
TAPP
TEP
Comparing
Two
Techniques

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