Preoperative Score of Inguinal Hernias. Is it Useful to P... | NCT04806828

Studies
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes

NCT04806828

Sponsor

Hospital del Mar

Status

Completed

Last Update Posted

Sep 14, 2021Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

Preoperative classification

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Sep 13, 2021Actual

First Submitted Date

Mar 11, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2021

Last Update Posted Date

Sep 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HF		Preoperative classification of inguinal hernia	Other: Preoperative classification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative classification	Other	Score of inguinal hernia	HF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Recurrent inguinal hernia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Inguinal hernia are more frequent in men and different characteristics

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients scheduled for a primary repair of inguinal hernia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
José Antonio Pereira	Parc de Salut Mar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
José Antonio Pereira		Barcelona		08031	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided