Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair: a Study Protocol for a Randomized Control Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Jul 30

PMID 35907909

Authors

K E Blake

S J Zolin

C Tu

K F Baier

L R Beffa

D Alaedeen

D M Krpata

A S Prabhu

M J Rosen

C C Petro

Affiliations

Soon will be listed here.

Abstract

Background: More than half of patients undergoing paraesophageal hernia repair (PEHR) will have radiographic hernia recurrence at 5 years after surgery. Gastropexy is a relatively low-risk intervention that may decrease recurrence rates, but it has not been studied in a prospective manner. Our study aims to evaluate the effect of anterior gastropexy on recurrence rates after PEHR, compared to no anterior gastropexy.

Methods: This is a two-armed, single-blinded, registry-based, randomized controlled trial comparing anterior gastropexy to no anterior gastropexy in PEHR. Adult patients (≥18 years) with a symptomatic paraesophageal hernia measuring at least 5 cm in height on computed tomography, upper gastrointestinal series, or endoscopy undergoing elective minimally invasive repair are eligible for recruitment. Patients will be blinded to their arm of the trial. All patients will undergo laparoscopic or robotic PEHR, where some operative techniques (crural closure techniques and fundoplication use or avoidance) are left to the discretion of the operating surgeon. During the operation, after closure of the diaphragmatic crura, participants are randomized to receive either no anterior gastropexy (control arm) or anterior gastropexy (treatment arm). Two hundred forty participants will be recruited and followed for 1 year after surgery. The primary outcome is radiographic PEH recurrence at 1 year. Secondary outcomes are symptoms of gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms as well as patient satisfaction in the immediate postoperative period and at 1-year follow-up. Outcome assessors will be blinded to the patients' intervention.

Discussion: This randomized controlled trial will examine the effect of anterior gastropexy on radiographic PEH recurrence and patient-reported outcomes. Anterior gastropexy has a theoretical benefit of decreasing PEH recurrence; however, this has not been proven beyond a suggestion of effectiveness in retrospective series. If anterior gastropexy reduces recurrence rates, it would likely become a routine component of surgical PEH management. If it does not reduce PEH recurrence, it will likely be abandoned.

Trial Registration: ClinicalTrials.gov NCT04007952 . Registered on July 5, 2019.

Citing Articles

Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial.

Petro C, Ellis R, Maskal S, Zolin S, Tu C, Costanzo A JAMA Surg. 2024; 160(3):247-255.

PMID: 39714889 PMC: 11904718. DOI: 10.1001/jamasurg.2024.5788.

References

Watson D, Thompson S, Devitt P, Aly A, Irvine T, Woods S . Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh. Ann Surg. 2020; 272(2):241-247. DOI: 10.1097/SLA.0000000000003734. View

Poncet G, Robert M, Roman S, Boulez J . Laparoscopic repair of large hiatal hernia without prosthetic reinforcement: late results and relevance of anterior gastropexy. J Gastrointest Surg. 2010; 14(12):1910-6. DOI: 10.1007/s11605-010-1308-6. View

Mehta S, Boddy A, Rhodes M . Review of outcome after laparoscopic paraesophageal hiatal hernia repair. Surg Laparosc Endosc Percutan Tech. 2006; 16(5):301-6. DOI: 10.1097/01.sle.0000213700.48945.66. View

Mattar S, Bowers S, Galloway K, Hunter J, Smith C . Long-term outcome of laparoscopic repair of paraesophageal hernia. Surg Endosc. 2002; 16(5):745-9. DOI: 10.1007/s00464-001-8194-7. View

Diaz S, Brunt L, Klingensmith M, Frisella P, Soper N . Laparoscopic paraesophageal hernia repair, a challenging operation: medium-term outcome of 116 patients. J Gastrointest Surg. 2003; 7(1):59-67. DOI: 10.1016/S1091-255X(02)00151-8. View

Le Page P, Furtado R, Hayward M, Law S, Tan A, Vivian S . Durability of giant hiatus hernia repair in 455 patients over 20 years. Ann R Coll Surg Engl. 2015; 97(3):188-93. PMC: 4474010. DOI: 10.1308/003588414X14055925060839. View

Frantzides C, Madan A, Carlson M, Stavropoulos G . A prospective, randomized trial of laparoscopic polytetrafluoroethylene (PTFE) patch repair vs simple cruroplasty for large hiatal hernia. Arch Surg. 2002; 137(6):649-52. DOI: 10.1001/archsurg.137.6.649. View

Luketich J, Nason K, Christie N, Pennathur A, Jobe B, Landreneau R . Outcomes after a decade of laparoscopic giant paraesophageal hernia repair. J Thorac Cardiovasc Surg. 2009; 139(2):395-404, 404.e1. PMC: 2813424. DOI: 10.1016/j.jtcvs.2009.10.005. View

Dindo D, Demartines N, Clavien P . Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2):205-13. PMC: 1360123. DOI: 10.1097/01.sla.0000133083.54934.ae. View

10.

Lidor A, Kawaji Q, Stem M, Fleming R, Schweitzer M, Steele K . Defining recurrence after paraesophageal hernia repair: correlating symptoms and radiographic findings. Surgery. 2013; 154(2):171-8. DOI: 10.1016/j.surg.2013.03.015. View

11.

Kohn G, Price R, DeMeester S, Zehetner J, Muensterer O, Awad Z . Guidelines for the management of hiatal hernia. Surg Endosc. 2013; 27(12):4409-28. DOI: 10.1007/s00464-013-3173-3. View

12.

Ponsky J, Rosen M, Fanning A, Malm J . Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003; 17(7):1036-41. DOI: 10.1007/s00464-002-8765-2. View

13.

Daigle C, Funch-Jensen P, Calatayud D, Rask P, Jacobsen B, Grantcharov T . Laparoscopic repair of paraesophageal hernia with anterior gastropexy: a multicenter study. Surg Endosc. 2014; 29(7):1856-61. DOI: 10.1007/s00464-014-3877-z. View

14.

Oelschlager B, Petersen R, Brunt L, Soper N, Sheppard B, Mitsumori L . Laparoscopic paraesophageal hernia repair: defining long-term clinical and anatomic outcomes. J Gastrointest Surg. 2012; 16(3):453-9. DOI: 10.1007/s11605-011-1743-z. View

15.

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. View

16.

Slankamenac K, Nederlof N, Pessaux P, De Jonge J, Wijnhoven B, Breitenstein S . The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014; 260(5):757-62. DOI: 10.1097/SLA.0000000000000948. View

17.

Wiechmann R, Ferguson M, Naunheim K, McKesey P, Hazelrigg S, Santucci T . Laparoscopic management of giant paraesophageal herniation. Ann Thorac Surg. 2001; 71(4):1080-6; discussion 1086-7. DOI: 10.1016/s0003-4975(00)01229-7. View

18.

Armijo P, Pokala B, Misfeldt M, Pagkratis S, Oleynikov D . Predictors of Hiatal Hernia Recurrence After Laparoscopic Anti-reflux Surgery with Hiatal Hernia Repair: a Prospective Database Analysis. J Gastrointest Surg. 2019; 23(4):696-701. DOI: 10.1007/s11605-018-04073-0. View

19.

Wang Z, Bright T, Irvine T, Thompson S, Devitt P, Watson D . Outcome for Asymptomatic Recurrence Following Laparoscopic Repair of Very Large Hiatus Hernia. J Gastrointest Surg. 2015; 19(8):1385-90. DOI: 10.1007/s11605-015-2807-2. View

20.

Oelschlager B, Pellegrini C, Hunter J, Brunt M, Soper N, Sheppard B . 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; 213(4):461-8. DOI: 10.1016/j.jamcollsurg.2011.05.017. View