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CompletedNCT05178446Updated Jan 5, 2022

GERD After Sleeve Gastrectomy

An observational study in Morbid Obesity and GERD, sponsored by University of Foggia. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-05.

Sponsored by University of Foggia · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
14,362
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However, the relationship between SG and GERD is complex. The aim of this study is to systematically evaluate all published data existing in the literature to evaluate the effect of sleeve gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of this procedure.

This systematic review was conducted in accordance with the guidelines for Preferred Reporting Items for Systematic Review and Meta-analyzes (PRISMA).

Published studies that contained outcome data for primary sleeve gastrectomy associated with the primary and secondary outcomes listed below were included.

02

Conditions studied

  • Morbid Obesity
  • GERD

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03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 14,362 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

University of Foggia is the lead sponsor of 35 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Obese patients underwent to sleeve gastrectomy with GERD symptoms

Inclusion criteria

  • Patients underwent to sleeve gastrectomy with reflux symptoms

Exclusion criteria

Exclusion Criteria:

  • Patients underwent to other bariatric procedures
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
14,362 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Gastroesophageal reflux disease after bariatric surgery

    Number of patients underwent sleeve gastrectomy with GERD

    Time frame: from 2014 to 2018

07

Study locations

1 site
  • University of Foggia
    Foggia, 71122, Italy
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References and documents

Publications

  • Pavone G, Tartaglia N, Porfido A, Panzera P, Pacilli M, Ambrosi A. The new onset of GERD after sleeve gastrectomy: A systematic review. Ann Med Surg (Lond). 2022 Apr 5;77:103584. doi: 10.1016/j.amsu.2022.103584. eCollection 2022 May. PubMed 35432994 ↗

Study documents

  • Study protocol · Dec 14, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05178446
Lead sponsor
University of Foggia
Responsible party
Giovanna Pavone (Medical Doctor, University of Foggia) — Principal investigator
First posted
Jan 5, 2022
Start date
Jan 1, 2021
Primary completion
Mar 1, 2021
Completion
Dec 1, 2021
Last update
Jan 5, 2022

Study contacts

Nicola Tartaglia
study director · University of Foggia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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