Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

NCT ID: NCT05416645

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-01-31

Brief Summary

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From January 2017 to January 2022, we looked at patients who had primary LSG and developed GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

Detailed Description

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Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to 65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from the trial.

The data were recorded in a prospective manner in a computerized file, all patients signed the informed consent form after the description of the technique and possible postoperative morbidities.

Before and after surgery, patients for LSG performed barium meal in Trendelenburg position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed GERD.

The study's purpose was to determine the prevalence of GERD symptoms, as well as potential predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.

Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.

Study Groups

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Patients in group I (G1) had GERD

Patients developed GERD after LSG

Group Type ACTIVE_COMPARATOR

patients with GERD after LSG

Intervention Type PROCEDURE

patients with GERD after LSG

Patients in group I (G2) had no GERD

Patients not developed GERD after LSG

Group Type ACTIVE_COMPARATOR

patients with GERD after LSG

Intervention Type PROCEDURE

patients with GERD after LSG

Interventions

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patients with GERD after LSG

patients with GERD after LSG

Intervention Type PROCEDURE

Other Intervention Names

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GERD after LSG

Eligibility Criteria

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Inclusion Criteria

* Patients with morbid obesity defined as a BMI of more than 40 or
* BMI less than 35 with at least one comorbidity and
* ages ranging from 16 to 65, were patients'

Exclusion Criteria

* Patients under the age of 16 or over 65,
* those with severe GERD,
* pregnancy, or
* inflammatory bowel disease,
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ayman El Nakeeb

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman El E Nakeeb

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Gastrointestinal Surgery Center

Locations

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Ayman El Nakeeb

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Emile SH, Ghareeb W, Elfeki H, El Sorogy M, Fouad A, Elrefai M. Development and Validation of an Artificial Intelligence-Based Model to Predict Gastroesophageal Reflux Disease After Sleeve Gastrectomy. Obes Surg. 2022 Aug;32(8):2537-2547. doi: 10.1007/s11695-022-06112-x. Epub 2022 May 21.

Reference Type RESULT
PMID: 35596915 (View on PubMed)

Chue KM, Goh DWX, Chua CME, Toh BC, Ong LWL, Wong WK, Lim CH, Tan JTH, Yeung BPM. The Hill's Classification Is Useful to Predict the Development of Postoperative Gastroesophageal Reflux Disease and Erosive Esophagitis After Laparoscopic Sleeve Gastrectomy. J Gastrointest Surg. 2022 Jun;26(6):1162-1170. doi: 10.1007/s11605-022-05324-x.

Reference Type RESULT
PMID: 35445323 (View on PubMed)

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.

Reference Type RESULT
PMID: 35432994 (View on PubMed)

Sancho Moya C, Bruna Esteban M, Sempere Garcia-Arguelles J, Ferrer Barcelo L, Monzo Gallego A, Mirabet Saez B, Mulas Fernandez C, Albors Baga P, Vazquez Prado A, Oviedo Bravo M, Montalva Oron E. The Impact of Sleeve Gastrectomy on Gastroesophageal Reflux Disease in Patients with Morbid Obesity. Obes Surg. 2022 Mar;32(3):615-624. doi: 10.1007/s11695-021-05808-w. Epub 2022 Jan 20.

Reference Type RESULT
PMID: 35048247 (View on PubMed)

El Nakeeb A, Aldossary H, Zaid A, El Sorogy M, Elrefai M, Attia M, Sewefy AM, Kayed T, Aldawsari MA, Al Dossari HM, Mohammed MM. Prevalence, Predictors, and Management of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy: a Multicenter Cohort Study. Obes Surg. 2022 Nov;32(11):3541-3550. doi: 10.1007/s11695-022-06264-w. Epub 2022 Sep 10.

Reference Type DERIVED
PMID: 36087223 (View on PubMed)

Study Documents

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Document Type: Study Protocol

Postlaparoscopic sleeve gastrectomy

View Document

Related Links

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http://www.mans.edu.eg/

mansoura university

Other Identifiers

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LSG

Identifier Type: -

Identifier Source: org_study_id

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