Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy (LSG-GERD)
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
patients with GERD after LSG
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring laparoscopic sleeve gastrectomy, morbid obesity, GERD
Eligibility Criteria
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,
Sites / Locations
- Ayman El Nakeeb
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients in group I (G1) had GERD
Patients in group I (G2) had no GERD
Arm Description
Patients developed GERD after LSG
Patients not developed GERD after LSG
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Gastropexy
YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD
smoking
YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416645
Brief Title
Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Acronym
LSG-GERD
Official Title
Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
January 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
laparoscopic sleeve gastrectomy, morbid obesity, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Masking
ParticipantInvestigator
Masking Description
Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Allocation
Non-Randomized
Enrollment
1537 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients in group I (G1) had GERD
Arm Type
Active Comparator
Arm Description
Patients developed GERD after LSG
Arm Title
Patients in group I (G2) had no GERD
Arm Type
Active Comparator
Arm Description
Patients not developed GERD after LSG
Intervention Type
Procedure
Intervention Name(s)
patients with GERD after LSG
Other Intervention Name(s)
GERD after LSG
Intervention Description
patients with GERD after LSG
Primary Outcome Measure Information:
Title
GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire
Description
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)
Time Frame
one month
Secondary Outcome Measure Information:
Title
Gastropexy
Description
YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD
Time Frame
one month
Title
smoking
Description
YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman El E Nakeeb
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
ZIP/Postal Code
356111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the study protocol will be available for another researcher
IPD Sharing Time Frame
available for any researcher at any time
IPD Sharing Access Criteria
e-mail elnakeebayman@yahoo.com
IPD Sharing URL
http://www.mans.edu.eg/
Citations:
PubMed Identifier
35596915
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 Aug;32(8):2537-2547. doi: 10.1007/s11695-022-06112-x. Epub 2022 May 21.
Results Reference
result
PubMed Identifier
35445323
Citation
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.
Results Reference
result
PubMed Identifier
35432994
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.
Results Reference
result
PubMed Identifier
35048247
Citation
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.
Results Reference
result
PubMed Identifier
36087223
Citation
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.
Results Reference
derived
Links:
URL
http://www.mans.edu.eg/
Description
mansoura university
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.mans.edu.eg/
Available IPD/Information Identifier
post LSG GERD
Available IPD/Information Comments
Postlaparoscopic sleeve gastrectomy
Learn more about this trial
Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
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