Evidence map›Paper›PMID 35907909›Full record

ArticleTrials2022

Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial.

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04007952 (Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04007952 nacompletednot on this map

Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair

TypeinterventionalSponsorClayton PetroRan2019 to 2024Enrolled240ConditionsParaesophageal Hernia, Hiatal Hernia LargeArmsAnterior Gastropexy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

K E BlakeDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA. kaelaparnell@gmail.com.ORCID http://orcid.org/0000-0002-9648-6193
S J ZolinDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
C TuDepartment of Quantitative Health Sciences, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
K F BaierDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
L R BeffaDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
D AlaedeenDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
D M KrpataDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
A S PrabhuDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
M J RosenDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
C C PetroDepartment of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, A10-133, Cleveland, OH, 44195, USA.
Cleveland Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore 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.

methodsThis 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 registrationClinicalTrials.gov NCT04007952 . Registered on July 5, 2019.

Indexed as

GastropexyHernia, HiatalLaparoscopyAdultHerniorrhaphyHumansProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeGastropexyHiatal herniaLaparoscopicOutcomesParaesophageal herniaRandomized control trialRecurrence

Identifiers

PMID35907909
PMCPMC9338471
OpenAlexW4288748727

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.