Clinical trial NCT04007952: Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair
Official title: Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraesophageal Hernia
Hiatal Hernia Large
Keywords: paraesophageal hernia
gastropexy
minimally invasive surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Paraesophageal Hernia Recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year
timeFrame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)
measure: Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year
timeFrame: 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
citation: 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. doi: 10.1007/s00464-002-8765-2. Epub 2003 Mar 28.
citation: 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.
citation: Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x.
citation: Blake KE, Zolin SJ, Tu C, Baier KF, Beffa LR, Alaedeen D, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial. Trials. 2022 Jul 30;23(1):616. doi: 10.1186/s13063-022-06571-8.