NCT00687375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

May 28, 2008

Last Update Submit

May 29, 2008

Conditions

Laparoscopic Inguinal Hernia Repair

Keywords

InguinalGroin herniaTAPPTEPComparingTwoTechniques

Outcome Measures

Primary Outcomes (2)

  • Operating time (in minutes)

    Two years

  • Cost of the procedure

    Two years

Secondary Outcomes (3)

  • Conversion rate

    Two years

  • Recurrence of hernia

    Two years

  • Major complications

    Two years

Study Arms (2)

1

OTHER

Laparoscopic Inguinal Hernia Repair- Transabdominal preperitoneal (TAPP) approach

Procedure: Laparoscopic Inguinal Hernia Repair

2

OTHER

Laparoscopic Inguinal Hernia Repair- Totally extra peritoneal (TEP) Approach

Procedure: Laparoscopic Inguinal Hernia Repair

Interventions

Laparoscopic Inguinal Hernia RepairPROCEDURE

Laparoscopic Inguinal Hernia Repair using Transabdominal preperitoneal (TAPP) Approach

Also known as: TAPP
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetra-4-amidinophenoxypropanetetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Subodh Kumar, MBBS, MS

    All India Institute of Medical Sciences, New Delhi-29, India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Subodh Kumar, MBBS, MS

CONTACT

91-11-2659-4776subodh6@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2008

Study Completion

March 1, 2009

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

IN(1)