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CompletedNCT06222177SLR obeseUpdated Jul 17, 2026

Thresholds of SLR Maneuver in Obese Patients

An observational study in Gastro Esophageal Reflux, sponsored by IRCCS Policlinico S. Donato. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by IRCCS Policlinico S. Donato · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study summary

There is an increasing interest in High resolution manometry (HRM) in the preoperative assessment of patients with obesity, in order to identify the best surgical option. Sleeve gastrectomy (SG) has been known to increase the risk of gastro-esophageal reflux disease (GERD). Different techniques have been recently developed and validated to offer to these patients protection against pathologic GERD after SG.

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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Conditions studied

  • Gastro Esophageal Reflux
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In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 150 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Obese patients with thorough pathophysiologic evaluation with or without suspect of GERD

Inclusion criteria

  • Complete and adequate HRM and pH-impedance study performed within 2 weeks
  • Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)
  • Obese with BMI>35 Kg/m2

Exclusion criteria

Exclusion Criteria:

  • Patients under the age of 18
  • Patients with prior foregut surgery
  • Paraesophageal hiatal hernia
  • Scleroderma
  • Eosinophilic esophagitis
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • GERD group

    Patients with AET\>6% at pH-study

    Diagnostic Test: Pathophysiologic evaluation

  • Non GERD group

    Patients with AET\<6% at pH-study

    Diagnostic Test: Pathophysiologic evaluation

Interventions

  • Diagnostic testPathophysiologic evaluation

    High-resolution manometry and pH study

06

What researchers measure

Primary outcomes

  1. Acid exposure time

    Time frame: January-March 2024

07

Study locations

1 site
  • IRCCS Policlinico San Donato
    San Donato Milanese, Milan 20097, Italy
08

References and documents

Publications

  • 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. PubMed 37466827 ↗
  • 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. PubMed 37935430 ↗
  • 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. PubMed 36270615 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06222177
Lead sponsor
IRCCS Policlinico S. Donato
Collaborators
Medical University of Vienna, University of Campania Luigi Vanvitelli, Università Vita-Salute San Raffaele
Responsible party
Sponsor
First posted
Jan 24, 2024
Start date
Jan 1, 2024
Primary completion
Jul 10, 2026
Completion
Jul 10, 2026
Last update
Jul 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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