Thresholds of SLR Maneuver in Obese Patients (SLR obese)

S

San Donato Group (GSD)

Status

Enrolling

Conditions

Gastro Esophageal Reflux

Treatments

Diagnostic Test: Pathophysiologic evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT06222177
SLR_Obese

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

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

Trial design

150 participants in 2 patient groups

GERD group
Description:
Patients with AET>6% at pH-study
Treatment:
Diagnostic Test: Pathophysiologic evaluation
Non GERD group
Description:
Patients with AET<6% at pH-study
Treatment:
Diagnostic Test: Pathophysiologic evaluation

Trial contacts and locations

1

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Central trial contact

Marco Sozzi; Stefano Siboni

Data sourced from clinicaltrials.gov

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