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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00687375
First received: May 28, 2008
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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 Intervention
Laparoscopic Inguinal Hernia Repair
Procedure: Laparoscopic Inguinal Hernia Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Operating time (in minutes) [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Cost of the procedure [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Conversion rate [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Recurrence of hernia [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Major complications [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: May 28, 2008
Last Updated: May 29, 2008
Health Authority: India: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014