NCT01117337

Brief Summary

The purpose of the study is

  1. 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. 2.To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 31, 2010

Completed
Last Updated

August 31, 2010

Status Verified

July 1, 2008

Enrollment Period

1.7 years

First QC Date

May 3, 2010

Results QC Date

July 7, 2010

Last Update Submit

August 9, 2010

Conditions

Inguinal Hernia

Keywords

Hernia, laparoscopic, recurrence, pain, inguinal

Outcome Measures

Primary Outcomes (2)

  • Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.

    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.

    1 year

  • Proportion of Patients Having Pain in the Post Operative Period

    To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.

    1 month

Secondary Outcomes (1)

  • Seroma Formation

    One year

Study Arms (1)

Mesh Non Fixation Group

NO INTERVENTION

Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed by ant means

Procedure: Mesh Fixation

Interventions

Mesh FixationPROCEDURE

Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure

Also known as: Mesh fixation by Tacker
Mesh Non Fixation Group

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All reducible inguinal hernias will be included in the study

You may not qualify if:

  • Irreducible hernia after anesthesia
  • Obstructed and strangulated hernias
  • Pediatric hernias
  • Associated other hernias like ventral hernias
  • Unfit for spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moulana Hospital

Perintalmanna, Kerala, 679322, India

Location

Related Publications (4)

  • Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.

    PMID: 18813990BACKGROUND

  • Taylor C, Layani L, Liew V, Ghusn M, Crampton N, White S. Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomised clinical trial. Surg Endosc. 2008 Mar;22(3):757-62. doi: 10.1007/s00464-007-9510-7. Epub 2007 Sep 21.

    PMID: 17885789BACKGROUND

  • Ferzli GS, Frezza EE, Pecoraro AM Jr, Ahern KD. Prospective randomized study of stapled versus unstapled mesh in a laparoscopic preperitoneal inguinal hernia repair. J Am Coll Surg. 1999 May;188(5):461-5. doi: 10.1016/s1072-7515(99)00039-3.

    PMID: 10235572BACKGROUND

  • Garg P, Nair S, Shereef M, Thakur JD, Nain N, Menon GR, Ismail M. Mesh fixation compared to nonfixation in total extraperitoneal inguinal hernia repair: a randomized controlled trial in a rural center in India. Surg Endosc. 2011 Oct;25(10):3300-6. doi: 10.1007/s00464-011-1708-z. Epub 2011 May 2.

    PMID: 21533969DERIVED

MeSH Terms

Conditions

Hernia, InguinalHerniaRecurrencePain

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Mohamed Ismail, Chief Consultant, Moulana Hospital, Perianthalmanna
Organization
Moulana Hospital
drgargpankaj@yahoo.com, mdismail13@gmail.com
0091-9447128511

Study Officials

  • Mohamed Ismail, MBBS, MS

    Moulana Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 31, 2010

Results First Posted

August 31, 2010

Record last verified: 2008-07

Locations

IN(1)