Clinical trial NCT06222177: Thresholds of SLR Maneuver in Obese Patients
Official title: Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro Esophageal Reflux
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: University of Campania Luigi Vanvitelli
name: Università Vita-Salute San Raffaele
First posted: 2024-01-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese patients with thorough pathophysiologic evaluation with or without suspect of GERD

Brief 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.


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

Primary outcomes:
measure: Acid exposure time
timeFrame: January-March 2024
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
References:
citation: 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 Symptoms 1 Year After Sleeve Gastrectomy. Obes Surg. 2023 Sep;33(9):2749-2757. doi: 10.1007/s11695-023-06732-x. Epub 2023 Jul 19.
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. 2024 Feb 29;37(3):doad063. doi: 10.1093/dote/doad063.
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, Schoppmann SF, Gyawali CP, Bonavina L. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-1770.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19.