NCT04891601

Brief Summary

A prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between January 2015 to February 2018. The duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. We randomly allocated it into two groups: mesh repair was applied to 166 patients (Group 1) and combined both mesh, and darn repair applied to 162 patients (Group 2).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
Last Updated

July 7, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

March 8, 2021

Last Update Submit

July 4, 2021

Conditions

Inguinal Hernia

Keywords

Adult inguinal herniaMeshDarn repairHernia repair techinquesPrimary inguinal hernia

Outcome Measures

Primary Outcomes (3)

  • Recurrence rate

    follow up

    two to four year

  • Post operative complications

    record complication

    two to four year

  • Post operative pain

    Visual Analog Score for pain

    two to four year

Study Arms (2)

Group II MA Mesh alone repair

ACTIVE COMPARATOR

patient use mesh alone as treatment of inguinal hernia

Procedure: polypropelene mesh

Group I CMD Combined Mesh & darn

ACTIVE COMPARATOR

patients utilize both mesh and darn repair

Procedure: polypropelene mesh

Interventions

polypropelene meshPROCEDURE

compare use mesh alone or combined mesh and darn repair

Group I CMD Combined Mesh & darnGroup II MA Mesh alone repair

Eligibility Criteria

Age16 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary hernia
  • male

You may not qualify if:

  • Female
  • bilateral
  • recurrent hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

May 18, 2021

Study Start

January 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2020

Last Updated

July 7, 2021

Record last verified: 2021-05