Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806828
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
José A. Pereira, Hospital del Mar

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes

Condition or disease Intervention/treatment
Inguinal Hernia Other: Preoperative classification

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : September 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
    Rate of postoperative complications


Secondary Outcome Measures :
  1. Lenght of operation [ Time Frame: Intraoperative ]
    Minutes of operation

  2. Recurrences [ Time Frame: 1 year ]
    Recurrences during follow-up


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Inguinal hernia are more frequent in men and different characteristics
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled for a primary repair of inguinal hernia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Recurrent inguinal hernia
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806828


Locations
Layout table for location information
Spain
José Antonio Pereira
Barcelona, Spain, 08031
Sponsors and Collaborators
Hospital del Mar
Investigators
Layout table for investigator information
Principal Investigator: José Antonio Pereira Parc de Salut Mar
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: José A. Pereira, Consultat of Surgery, Hospital del Mar
ClinicalTrials.gov Identifier: NCT04806828    
Other Study ID Numbers: POINTHER
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José A. Pereira, Hospital del Mar:
Inguinal Hernia
Preoperative Score
Kingsnorth Score
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal