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NCT06222177Completed

Thresholds of SLR Maneuver in Obese Patients

Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
15 Jan 2024
Start date
1 Jan 2024
Primary completion date
10 Jul 2026
Lead sponsor
IRCCS Policlinico S. Donato
Diseases
Obesity
NCT number
NCT06222177

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 1 Jan 2024 to the primary completion date, 10 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with prior foregut surgery

Age

  • Patients under the age of 18

Other

  • Paraesophageal hiatal hernia
  • Scleroderma
  • Eosinophilic esophagitis
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
IRCCS Policlinico San Donato
Coordinator of this site? Confirm its status
San Donato MilaneseItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.