Hiatus Hernia in Old | NCT06935617

Studies
Hiatus Hernia in Old

NCT06935617

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Apr 20, 2025Actual

Enrollment

266Actual

Phase

Not provided

Conditions

Hiatus Hernia

Interventions

nissein

Countries

Not provided

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

Apr 2025

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

Mar 1, 2016Actual

Primary Completion Date

Mar 1, 2022Actual

Completion Date

Mar 1, 2025Actual

First Submitted Date

Apr 13, 2025

First Submission Date that Met QC Criteria

Apr 13, 2025

First Posted Date

Apr 20, 2025Actual

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

Apr 13, 2025

Last Update Posted Date

Apr 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tamer.A.A.M.Habeeb, prof of general surgery, laparoscopic and GIT surgery, Zagazig UniversityPrincipal Investigator

Lead Sponsor

Zagazig UniversityOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

266Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hiatus hernia		HH operated by LNF	Procedure: nissein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nissein	Procedure	nissein surgery	hiatus hernia

Measure	Description	Time Frame
recurrence		three years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

EP aged ≥60 years for giant sliding HH with

Exclusion Criteria:

• who required a concurrent abdominal procedure at the same time as fundoplication (e.g., cholecystectomy)(n=5)
- esophageal dysmotility(n=2)
- progressive systemic sclerosis (n=1)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

elderly pt with hh

Sampling Method

Non-Probability Sample

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
D006551	Hernia, Hiatal

Ancestor Terms

ID	Term
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia
D006547	Hernia
D020763	Pathological Conditions, Anatomical

Browse Leaves

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Browse Branches

Not provided