Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2024-01-01
2024-06-01
Brief Summary
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A recent study found a significant correlation between straight leg raise (SLR) maneuver during HRM and a positive pH-study. However, these maneuver has not been validated in an obese population, therefore the normality cut-off remain unknown.
A multicenter study with a large number of patients undergoing pre-operative assessment for bariatric surgery could provide a precise threshold to predict pathologic esophageal acid exposure time.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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GERD group
Patients with AET\>6% at pH-study
Pathophysiologic evaluation
High-resolution manometry and pH study
Non GERD group
Patients with AET\<6% at pH-study
Pathophysiologic evaluation
High-resolution manometry and pH study
Interventions
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Pathophysiologic evaluation
High-resolution manometry and pH study
Eligibility Criteria
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Inclusion Criteria
* Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)
* Obese with BMI\>35 Kg/m2
Exclusion Criteria
* Patients with prior foregut surgery
* Paraesophageal hiatal hernia
* Scleroderma
* Eosinophilic esophagitis
* Pregnancy
18 Years
75 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
University of Campania Luigi Vanvitelli
OTHER
Università Vita-Salute San Raffaele
OTHER
IRCCS Policlinico S. Donato
OTHER
Responsible Party
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Locations
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IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Bonaldi M, Rubicondo C, Andreasi V, Giorgi R, Cesana G, Ciccarese F, Uccelli M, Zanoni A, Villa R, De Carli S, Oldani A, Dokic D, Olmi S. Role of Preoperative High-Resolution Manometry in the Identification of Patients at High Risk of Postoperative GERD Symptoms 1 Year After Sleeve Gastrectomy. Obes Surg. 2023 Sep;33(9):2749-2757. doi: 10.1007/s11695-023-06732-x. Epub 2023 Jul 19.
Memon MA, Osland E, Yunus RM, Alam K, Hoque Z, Khan S. Gastroesophageal reflux disease following laparoscopic vertical sleeve gastrectomy and laparoscopic roux-en-Y gastric bypass: meta-analysis and systematic review of 5-year data. Dis Esophagus. 2024 Feb 29;37(3):doad063. doi: 10.1093/dote/doad063.
Siboni S, Kristo I, Rogers BD, De Bortoli N, Hobson A, Louie B, Lee YY, Tee V, Tolone S, Marabotto E, Visaggi P, Haworth J, Ivy M, Greenan G, Facchini C, Masuda T, Yano F, Perry K, Balasubramanian G, Theodorou D, Triantafyllou T, Cusmai L, Boveri S, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19.
Other Identifiers
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SLR_Obese
Identifier Type: -
Identifier Source: org_study_id
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