Thresholds of Straight Leg Raise Maneuver During High-Resolution-Manometry

Summary

High resolution manometry (HRM) is a key test in the preoperative assessment of patients with gastro-esophageal reflux disease (GERD) who are potential candidates for antireflux surgery. The recent Lyon consensus suggested the potential usefulness of HRM in diagnosing GERD, however, sensitivity and specificity of HRM for GERD remains low (53.6% and 72.5% respectively). Among recently proposed provocative tests during manometry, a traditional maneuver (straight leg raise maneuver, SLR) appeared promising in predicting reflux.

This is a multicenter study involving high-volume esophageal function laboratories around the world. Patients with suspected GERD and tested with HRM and pH-impedance will be asked to perform SLR during HRM. Intra-abdominal and intra-esophageal pressure during SLR will be recorded and compared with acid exposure time (AET) at pH-impedance.

Primary aim is to determine the optimal threshold of intra-esophageal pressure augmentation during straight leg raise (SLR) maneuver that predicts pathological esophageal acid exposure time (AET). Secondary aim is to assess the diagnostic performance of HMR with SRL maneuver, calculating sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), positive predictive value and total misclassification rate.

Conditions

• Gastroesophageal Reflux

Interventions

PROCEDURE

Straight leg raise maneuver

With the patient in supine position, one leg is raised to form an angle of at least 45 degrees with the bed. The patient will be asked to keep that position for at least 5 seconds. The maneuver will be repeated after 20-30 seconds. The first adequate maneuver will be considered for the study. Intra-esophageal and intra-abdominal pressure will be analyzed both during baseline and SLR maneuver. Intra-esophageal pressure is measured as peak and mean over 5 seconds, 1 cm and 5 cm above the proximal margin of the LES. Intra-abdominal pressure will be measured as peak and mean over 5 seconds 1 cm below the distal margin of the diaphragm notch.

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• University Hospital Padova

  collaborator OTHER

• University of Missouri, St. Louis

  collaborator OTHER

• Hospital Universiti Sains Malaysia

  collaborator OTHER

• The Oregon Clinic

  collaborator OTHER

• The Functional Gut Clinic

  collaborator OTHER

• University of Texas at Austin

  collaborator OTHER

• University of Athens

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• Jikei University School of Medicine

  collaborator OTHER

• University of Milan

  lead OTHER

Principal Investigators

• Luigi Bonavina, MD · University of Milan

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2021-12-30

Completion

2021-12-30

Countries

• Italy

Study Locations