Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

NCT04007952 | Completed

• 1 other identifier: 19-616
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraesophageal Hernia; Hiatal Hernia Large

Keywords

paraesophageal hernia; gastropexy; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• Paraesophageal Hernia Recurrence

  Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence

  1 year

Secondary Outcomes (2)

• Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year

  30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)

• Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year

  30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months)

Study Arms (2)

Intervention 1 (Control)

NO INTERVENTION

No anterior gastropexy will be performed.

Intervention 2 (Treatment)

EXPERIMENTAL

Anterior gastropexy will be performed.

Procedure: Anterior Gastropexy

Interventions

Anterior Gastropexy PROCEDURE

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.

Intervention 2 (Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clayton Petro: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

• 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.

  PMID: 12658421 BACKGROUND

• 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.

  PMID: 21715189 BACKGROUND

• 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.

  PMID: 17439596 BACKGROUND

• Petro CC, Ellis RC, Maskal SM, Zolin SJ, Tu C, Costanzo A, Beffa LRA, Krpata DM, Alaedeen D, Prabhu AS, Miller BT, Baier KF, Fathalizadeh A, Rodriguez J, Rosen MJ. Anterior Gastropexy for Paraesophageal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2025 Mar 1;160(3):247-255. doi: 10.1001/jamasurg.2024.5788.

  PMID: 39714889 DERIVED

• 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.

  PMID: 35907909 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: June 26, 2019
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)