NCT04683367

Brief Summary

The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

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, 2003

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

17.9 years

First QC Date

December 16, 2020

Last Update Submit

December 21, 2020

Conditions

Hernia, InguinalHernia, VentralLaparoscopy

Keywords

inguinal herniaventral hernialaparoscopic diagnosis

Outcome Measures

Primary Outcomes (1)

  • number of operated hernia

    occult hernia operated because of symptoms

    15 years

Secondary Outcomes (1)

  • number of symptomatic hernia

    15 years

Study Arms (1)

clinical hernia

EXPERIMENTAL

developing clinical hernia

Procedure: laparoscopic surgery

Interventions

laparoscopic surgeryPROCEDURE

laparoscopic repair of hernia

Also known as: hernioplasty
clinical hernia

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • occult inguinal or ventral hernia diagnosed in laparoscopic surgery

You may not qualify if:

  • clinically diagnosed inguinal or ventral hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70600, Finland

Location

MeSH Terms

Conditions

Hernia, InguinalHernia, Ventral

Interventions

LaparoscopyHerniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Hannu EK Paajanen, MD, PhD

    department of Surgery, Kuopio Univ Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 24, 2020

Study Start

January 1, 2003

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

FI(1)