Thresholds of SLR Maneuver in Obese Patients

Gastro Esophageal Reflux Clinical Trial

— SLR obese  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222177
• Other study ID #: SLR_Obese
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: IRCCS Policlinico S. Donato
• Contact: Stefano Siboni
• Phone: +393493232750
• Email: stefano.siboni[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Diagnostic Test:
• Pathophysiologic evaluation
High-resolution manometry and pH study

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Medical University of Vienna, Università Vita-Salute San Raffaele, University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 S — View Citation

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. 2023 No — View Citation

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, Schop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acid exposure time		January-March 2024