NCT04806828

Brief Summary

To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 11, 2021

Last Update Submit

September 13, 2021

Conditions

Inguinal Hernia

Keywords

Inguinal HerniaPreoperative ScoreKingsnorth Score

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Rate of postoperative complications

    30 days

Secondary Outcomes (2)

  • Lenght of operation

    Intraoperative

  • Recurrences

    1 year

Study Arms (1)

HF

Preoperative classification of inguinal hernia

Other: Preoperative classification

Interventions

Preoperative classificationOTHER

Score of inguinal hernia

HF

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsInguinal hernia are more frequent in men and different characteristics
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for a primary repair of inguinal hernia

You may qualify if:

  • Male sex
  • Age \> 18 years
  • Primary inguinal hernia
  • Unilateral hernia
  • Elective surgery

You may not qualify if:

  • Recurrent inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Antonio Pereira

Barcelona, 08031, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • José Antonio Pereira

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultat of Surgery

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 19, 2021

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

September 13, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)