Effect of Hernia Sac Excision on Crural Tension in Paraes... | NCT07197619

Studies
Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair

NCT07197619

Sponsor

Corewell Health West

Status

Recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

42Estimated

Phase

Not provided

Conditions

Paraesophageal Hernia

Interventions

Not provided

Countries

United States

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 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2021Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Feb 26, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 29, 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

Sep 22, 2025

Last Update Posted Date

Sep 29, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Repair of a paraesophageal hernia is associated with significant recurrence rate, with primary repair often in excess of 50%. Hernia recurrence and revisional surgery significantly increase the likelihood of complications and decreased quality of life.

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

42Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Outcome	Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.	Immediately following procedure

Secondary Outcomes

Measure	Description	Time Frame
Competeness of hernia sac excision	Determining whether the hernia sac excision was complteted or partial	Immediately following procedure
Paraesophageal hernia type	Comparing the paraesophageal hernia type

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.

Exclusion Criteria:

Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Corewell Health General Surgery Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
kendra Selby	Contact	616-486-0281		kendra.selby@helendevoschildrens.org
Rachel Gross, BSN	Contact	616-391-3825		rachel.gross@corewellhealth.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corewell Health	Recruiting	Grand Rapids	Michigan	49503	United States

Condition Browse Module

MeSH Terms

ID	Term
D006551	Hernia, Hiatal
D006547	Hernia

Ancestor Terms

ID	Term
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided