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

Gastroesophageal Reflux Clinical Trial

— LSG-GERD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416645
• Other study ID #: LSG
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2022

Study information

• Verified date: January 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1537
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

Procedure:
• patients with GERD after LSG
patients with GERD after LSG

Locations

Country	Name	City	State
Egypt	Ayman El Nakeeb	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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 — View Citation

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 May 21. doi: 10.1007/s11695-022-06112 — View Citation

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. Review. — View Citation

Sancho Moya C, Bruna Esteban M, Sempere García-Argüelles J, Ferrer Barceló L, Monzó Gallego A, Mirabet Sáez B, Mulas Fernández C, Albors Bagá P, Vázquez Prado A, Oviedo Bravo M, Montalvá Orón E. The Impact of Sleeve Gastrectomy on Gastroesophageal Reflux — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire	GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire including GERD symptoms easch one scaled from 1 to 5 the less score the better out come (1 the best and 5 is the worset)	one month
Secondary	Gastropexy	YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD	one month
Secondary	smoking	YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD	one month

External Links

•   mansoura university