Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes (POINTHER)

September 13, 2021 updated by: José A. Pereira, Hospital del Mar
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08031
        • José Antonio Pereira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for a primary repair of inguinal hernia

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent inguinal hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HF
Preoperative classification of inguinal hernia
Other: Preoperative classification
Score of inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
Rate of postoperative complications
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lenght of operation
Time Frame: Intraoperative
Minutes of operation
Intraoperative
Recurrences
Time Frame: 1 year
Recurrences during follow-up
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Investigators

  • Principal Investigator: José Antonio Pereira, Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

September 13, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POINTHER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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