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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Paraesophageal Hernia Recurrence

Secondary outcome measures

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

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

0 / 3Eligibility criteria met

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

1,026 Previous Clinical Trials

1,365,836 Total Patients Enrolled

1 Trials studying Paraesophageal Hernia

164 Patients Enrolled for Paraesophageal Hernia

Media Library

Anterior Gastropexy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007952 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still open to recruitment?

"Affirmative. On clinicaltrials.gov, the details of this medical trial confirm that it is currently seeking participants, having first appeared on June 26th 2019 and most recently updated on December 21st 2021. The study aims to recruit 240 patients from a single site."

Answered by AI

What is the estimated number of participants in this research endeavor?

"That is correct. As stated on clinicaltrials.gov, the trial which was first publicized on June 26th 2019 is actively recruiting patients with a targeted enrolment of 240 individuals at one medical centre."

Answered by AI

Recent research and studies

Surgical EndoscopyJournal

Anterior Gastropexy May Reduce the Recurrence Rate After Laparoscopic Paraesophageal Hernia Repair

Malm, J., M. Rosen, J. Ponsky, and A. Fanning. 2003. “Anterior Gastropexy May Reduce the Recurrence Rate After Laparoscopic Paraesophageal Hernia Repair”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-002-8765-2.

Journal of the American College of SurgeonsJournal

Biologic Prosthesis to Prevent Recurrence After Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial

Oelschlager, Brant K., Carlos A. Pellegrini, John G. Hunter, Michael L. Brunt, Nathaniel J. Soper, Brett C. Sheppard, Nayak L. Polissar, et al.. 2011. “Biologic Prosthesis to Prevent Recurrence After Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2011.05.017.

Diseases of the EsophagusJournal

The Development of the GERD-HRQL Symptom Severity Instrument

Velanovich, V.. 2007. “The Development of the GERD-HRQL Symptom Severity Instrument”. Diseases of the Esophagus. Oxford University Press (OUP). doi:10.1111/j.1442-2050.2007.00658.x.

TrialsJournal