NCT03860285

Brief Summary

This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

March 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

5.8 years

First QC Date

December 2, 2018

Last Update Submit

March 12, 2023

Conditions

Inguinal HerniaQuality of LifeSurgerySurvey

Keywords

inguinal herniaquality of lifesurveysurgerypamplonaprospectiveobservationalcohorts

Outcome Measures

Primary Outcomes (1)

  • Obtaining objective and perceived quality of life

    Obtaining data about objective and perceived quality of life of patients undergoing elective inguinal hernia surgery in Pamplona during a year to compare them with international quality standards

    4 years

Secondary Outcomes (6)

  • Knowing patients' pain

    4 years

  • Registering hernia recurrence

    4 years

  • Controlling presence or not of complications

    4 years

  • Knowing patient satisfaction

    4 years

  • Knowing duration of sick leave

    4 years

  • +1 more secondary outcomes

Interventions

Short form 36 quality of life surveyOTHER

Prospective non-comparative observational study of cohorts

Also known as: European Hernia Society Survey

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective inguinal hernia surgery en Pamplona

You may qualify if:

  • Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
  • Elective surgery.

You may not qualify if:

  • Age below 16.
  • Mental diseases.
  • Patients not capable of understanding the study.
  • Patients that reject entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de navarra

Pamplona, Navarre, 31003, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Concepción Yárnoz-Irazabal, PhD

    Hospital de Navarra

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon, Senior

Study Record Dates

First Submitted

December 2, 2018

First Posted

March 1, 2019

Study Start

March 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

ES(1)