NCT03765268

Brief Summary

It is a randomized controlled trial in which we are treating inguinal hernia patients with mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy or preservation comparing post operative acute or chronic pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

July 13, 2018

Last Update Submit

February 2, 2019

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • percentage of patients developing chronic inguinodynia

    Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia

    3 months

Study Arms (2)

Neurectomy

ACTIVE COMPARATOR

In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve

Procedure: Neurectomy in inguinal hernia repair

Nerve Sparing

ACTIVE COMPARATOR

In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve

Procedure: nerve sparing in inguinal hernia repair

Interventions

Neurectomy in inguinal hernia repairPROCEDURE

Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve

Neurectomy
nerve sparing in inguinal hernia repairPROCEDURE

Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve

Nerve Sparing

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients male, and age between 20 to 70 years Reducible inguinal hernia

You may not qualify if:

  • Irreducible, obstructed or strangulated hernia uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Denervation

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 13, 2018

First Posted

December 5, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

PA(1)