NCT04888078

Brief Summary

Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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, 2006

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

9 years

First QC Date

May 11, 2021

Last Update Submit

May 11, 2021

Conditions

Inguinal HerniaSurgery--ComplicationsSurgical Complication

Outcome Measures

Primary Outcomes (1)

  • Inguinal hernia recurrence

    chart review

    5-13 years postoperatively

Secondary Outcomes (5)

  • wound infection

    5-13 years

  • urinary retention

    5-13 years

  • groin pain

    5-13 years

  • durability of repair

    5-13 years postop

  • testicular ischemia

    5-13 years

Interventions

Bassini hernia repairPROCEDURE

Non-mesh tissue inguinal hernia repairs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans who underwent inguinal hernia repair without mesh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VAMC

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Surgery

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 17, 2021

Study Start

January 1, 2006

Primary Completion

December 31, 2014

Study Completion

December 31, 2019

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

All personally identifiable information is secured. Study outcomes reported in aggregate only.

Locations

US(1)