NCT06862167

Brief Summary

This study aims to compare Desarda's technique and Lichtenstein's technique of hernia repair in managing elective, non-complicated inguinal hernia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 15, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 1, 2025

Last Update Submit

March 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative complications

    Incidence of postoperative complications such as groin pain, hemorrhage, orchitis, testicular atrophy, and seroma will be recorded.

    1 year postoperatively

Secondary Outcomes (3)

  • Time till stop of postoperative analgesic

    30 days postoperatively

  • Return to normal activity

    30 days postoperatively

  • Incidence of recurrence

    1 year postoperatively

Study Arms (2)

Desarda's technique group

EXPERIMENTAL

Patients will undergo Desarda's technique.

Procedure: Desarda's technique

Lichtenstein's technique group

ACTIVE COMPARATOR

Patients will undergo Lichtenstein's technique.

Procedure: Lichtenstein's technique

Interventions

Patients will undergo Desarda's technique.

Desarda's technique group

Patients will undergo Lichtenstein's technique.

Lichtenstein's technique group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Above 14 years of age.
  • With reducible non-complicated inguinal or inguinoscrotal hernia; unilateral or bilateral

You may not qualify if:

  • Obstructive uropathy or chronic obstructive pulmonary disease because they are contraindications to elective hernia surgery. They are associated with definite poor outcomes, such as high recurrence rates.
  • Unfit patients for surgery
  • Patients with strangulated hernia.
  • Recurrent Hernias.
  • Per operative finding of separated, thin, and/or weak external oblique aponeurosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61611, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Abdelrahman M Salah, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in General Surgery Department, Minia University, Minia, Egypt

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

August 15, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations