Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

Overview

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.

Full Title of Study: “Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Intervention 1 (Control)
    • No anterior gastropexy will be performed.
  • Experimental: Intervention 2 (Treatment)
    • Anterior gastropexy will be performed.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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 (9-15 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.
  • 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 (9-15 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Clayton Petro, Assistant Professor – The Cleveland Clinic
  • Overall Contact(s)
    • Clayton C Petro, MD, 216-444-3501, PETROC@ccf.org

References

Ponsky J, Rosen M, Fanning A, Malm J. Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003 Jul;17(7):1036-41. Epub 2003 Mar 28.

Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29. Erratum in: J Am Coll Surg. 2011 Dec;213(6):815.

Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4.

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