NCT06222177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

January 15, 2024

Last Update Submit

July 16, 2026

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Acid exposure time

    January-March 2024

Study Arms (2)

GERD group

Patients with AET\>6% at pH-study

Diagnostic Test: Pathophysiologic evaluation

Non GERD group

Patients with AET\<6% at pH-study

Diagnostic Test: Pathophysiologic evaluation

Interventions

Pathophysiologic evaluationDIAGNOSTIC_TEST

High-resolution manometry and pH study

GERD groupNon GERD group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obese patients with thorough pathophysiologic evaluation with or without suspect of GERD

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related 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 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.

    PMID: 37466827RESULT

  • 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.

    PMID: 37935430RESULT

  • 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.

    PMID: 36270615RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

January 1, 2024

Primary Completion

July 10, 2026

Study Completion

July 10, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)