NCT04450628

Brief Summary

The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2020Sep 2026

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 25, 2026

Status Verified

July 1, 2025

Enrollment Period

5.4 years

First QC Date

June 25, 2020

Last Update Submit

March 24, 2026

Conditions

Esophagogastric Junction DistensibilityHiatal Hernia

Keywords

EndoFLIPDistensibility of the esophagogastric junctionGastroesophageal Reflux Disease-Health Related Quality of Life surveyMayo Dysphagia Questionnaire

Outcome Measures

Primary Outcomes (1)

  • Change in distensibility index

    Distensibility index of esophagogastric junction will be measured 8cm EndoFLIP balloon at baseline and after hiatal hernia repair.

    Baseline to day 1

Secondary Outcomes (2)

  • Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL) Score

    baseline, postop week 2, postop week 6, postop month 6

  • Mayo Dysphagia Questionnaire (MDQ-30) Score

    baseline, postop week 2, postop week 6, postop month 6

Study Arms (1)

Hiatal Hernia Repair Patients

EXPERIMENTAL

Patients undergoing hiatal hernia repair (types I-IV included) and fundoplication

Device: EndoFLIP

Interventions

EndoFLIPDEVICE

Intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the esophagogastric junction using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.

Hiatal Hernia Repair Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
  • Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry
  • Adult patients ≥18 years
  • Elective repairs

You may not qualify if:

  • Redo hiatal hernia repairs
  • Emergent repairs
  • Patients with contraindication to surgery or endoscopy
  • Patients with esophageal varices
  • Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
  • Connective tissue diseases such as scleroderma or lupus
  • Diameter measurements less than 5 mm as the EF-325N catheter is not suitable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Paul D Colavita, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

September 28, 2020

Primary Completion

March 2, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 25, 2026

Record last verified: 2025-07

Locations

US(1)