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Anterior Gastropexy for Hiatal Hernia

N/A
Waitlist Available
Research Sponsored by Clayton Petro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Crura must be reapproximated at time of surgery
Symptomatic paraesophageal hernia
Must not have
Emergent operation for acute gastric volvulus
Previous operations of the esophagus or stomach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether attaching the stomach to the inner abdominal wall will help prevent paraesophageal hernias from recurring.

Who is the study for?
This trial is for adults over 18 with a symptomatic paraesophageal hernia that's at least 5cm tall, as seen on an upper GI study or endoscopy. They must be able to do follow-ups and are scheduled for elective laparoscopic hernia repair, which can switch to open surgery if needed. It's not for those who've had previous esophagus/stomach surgeries, emergency operations for twisted stomachs, or need a feeding tube or weight-loss related procedures.
What is being tested?
The study tests whether anterior gastropexy (stitching the stomach to the abdominal wall) prevents paraesophageal hernias from coming back after repair surgery. Participants will be randomly divided into two groups: one receiving gastropexy and the other not, to compare outcomes.
What are the potential side effects?
Potential side effects of anterior gastropexy may include discomfort at the suture site, infection risk from surgical intervention, possible injury to surrounding organs during procedure and complications affecting stomach position.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery will involve stitching the crura together.
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I have symptoms from a hernia near my esophagus.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need immediate surgery for a twisted stomach.
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I have had surgery on my esophagus or stomach before.
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I had surgery to fix a hernia near my esophagus and surgery to make my stomach smaller at the same time.
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I have a feeding tube in my stomach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Paraesophageal Hernia Recurrence
Secondary study objectives
Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year
Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention 2 (Treatment)Experimental Treatment1 Intervention
Anterior gastropexy will be performed.
Group II: Intervention 1 (Control)Active Control1 Intervention
No anterior gastropexy will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anterior Gastropexy
2019
N/A
~240

Find a Location

Who is running the clinical trial?

Clayton PetroLead Sponsor
4 Previous Clinical Trials
1,392 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,053 Previous Clinical Trials
1,370,934 Total Patients Enrolled

Media Library

Anterior Gastropexy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007952 — N/A
~38 spots leftby Nov 2025
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