Search / Trial NCT06222177

Thresholds of SLR Maneuver in Obese Patients

Launched by IRCCS POLICLINICO S. DONATO · Jan 15, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "Thresholds of SLR Maneuver in Obese Patients," is looking into how a specific test called the straight leg raise (SLR) can help predict issues with acid reflux in obese patients who are considering weight loss surgery, specifically sleeve gastrectomy. This surgery can sometimes lead to gastro-esophageal reflux disease (GERD), which is when stomach acid frequently flows back into the esophagus, causing discomfort. The study aims to determine a reliable measure for the SLR test in obese individuals to better assess their risk of this condition.

To join the study, participants must be adults aged 18 and older with a body mass index (BMI) over 35, and they need to have had certain tests (high-resolution manometry and pH-impedance study) done recently. Participants should be able to successfully perform the SLR maneuver, which helps measure pressure in the abdomen. Those with previous stomach surgeries, certain medical conditions, or who are pregnant cannot take part. If someone is eligible, they can expect to undergo additional tests to help researchers find the best ways to protect against acid reflux after surgery.

Gender

ALL

Eligibility criteria

  • 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

About Irccs Policlinico S. Donato

IRCCS Policlinico S. Donato is a leading Italian research hospital and clinical trial sponsor dedicated to advancing medical science through innovative research and patient care. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it is recognized for its commitment to high-quality clinical research and the integration of scientific investigation with clinical practice. The institution specializes in various medical fields, including cardiology, oncology, and neurology, and collaborates with universities and research organizations to facilitate cutting-edge studies. With a focus on improving patient outcomes and contributing to public health, IRCCS Policlinico S. Donato plays a pivotal role in the development of new therapies and treatment protocols.

Locations

San Donato Milanese, Milan, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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