NCT02329938

Brief Summary

Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

December 30, 2014

Last Update Submit

December 30, 2014

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • number of patients with recurrence of inguinal hernia

    2 years

Secondary Outcomes (2)

  • VAS score for pain

    one year

  • number of patients develped postoperative complications

    2 years

Study Arms (2)

Lichtenstein tension free reair

ACTIVE COMPARATOR

mesh repair of inguinal hernia

Procedure: Lichtenstein tension free reair

Desarda's repair

ACTIVE COMPARATOR

non-mesh repair of inguinal hernia

Procedure: Desarda's repair

Interventions

Lichtenstein tension free reairPROCEDURE

a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.

Also known as: pure synthetic repair
Lichtenstein tension free reair
Desarda's repairPROCEDURE

the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.

Also known as: pure tissue reapir
Desarda's repair

Eligibility Criteria

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

You may qualify if:

  • inguinal hernia

You may not qualify if:

  • recurrent inguinal hernia
  • giant inguinal hernia
  • mental disorder
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Youssef T, El-Alfy K, Farid M. Randomized clinical trial of Desarda versus Lichtenstein repair for treatment of primary inguinal hernia. Int J Surg. 2015 Aug;20:28-34. doi: 10.1016/j.ijsu.2015.05.055. Epub 2015 Jun 11.

    PMID: 26074293DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of surgery

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 1, 2015

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

January 1, 2015

Record last verified: 2014-12