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Trial record 1 of 1 for:    NCT04007952 | Paraesophageal Hernia
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Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

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ClinicalTrials.gov Identifier: NCT04007952
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Clayton Petro, The Cleveland Clinic

Brief Summary:
This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

Condition or disease Intervention/treatment Phase
Paraesophageal Hernia Hiatal Hernia Large Procedure: Anterior Gastropexy Not Applicable

Detailed Description:

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a double-blinded, registry-based, randomized control trial comparing anterior gastropexy to no anterior gastropexy in paraesophageal hernia repair. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not be informed regarding the treatment that they received until they complete 1-year follow-up. Imaging will be reviewed at the end of the study period by surgeons who are blinded to treatment group.
Primary Purpose: Treatment
Official Title: Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
No Intervention: Intervention 1 (Control)
No anterior gastropexy will be performed.
Experimental: Intervention 2 (Treatment)
Anterior gastropexy will be performed.
Procedure: Anterior Gastropexy
Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.




Primary Outcome Measures :
  1. Paraesophageal Hernia Recurrence [ Time Frame: 1 year ]
    Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence


Secondary Outcome Measures :
  1. Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) ]
    The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease. Scores on individual items are summed and may range from 0 to 50, with higher scores indicating greater severity of symptoms and worse quality of life. Additionally, there is a question about global satisfaction with quality of life, which may be answered as "satisfied," "neutral," or "dissatisfied." The percentages of these categories will be reported.

  2. Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months) ]
    Eight symptoms that are potentially related to the presence of a paraesophageal hernia will be assessed on a scale ranging from 0 to 10, with higher scores indicating more significant impact on quality of life. Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. Each symptom will be reported separately.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+
  • Able to participate in follow-up
  • Symptomatic paraesophageal hernia
  • Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
  • Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
  • Crura must be reapproximated at time of surgery

Exclusion Criteria:

  • Previous operations of the esophagus or stomach
  • Emergent operation for acute gastric volvulus
  • Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
  • Placement of gastrostomy tube

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007952


Contacts
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Contact: Clayton C Petro, MD 216-444-3501 PETROC@ccf.org
Contact: Samuel J Zolin, MD 216-308-2412 zolins@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clayton C Petro, MD    216-444-3501    PETROC@ccf.org   
Contact: Samuel J Zolin, MD    216-308-2412    zolins@ccf.org   
Principal Investigator: Clayton C Petro, MD         
Sponsors and Collaborators
The Cleveland Clinic
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clayton Petro, Assistant Professor, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04007952    
Other Study ID Numbers: 19-616
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clayton Petro, The Cleveland Clinic:
paraesophageal hernia
gastropexy
minimally invasive surgery
Additional relevant MeSH terms:
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Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Hernia, Diaphragmatic
Internal Hernia