Gastroesophageal RefluxLSG-GERDNCT05416645
Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
A study testing patients with GERD after LSG in people with Gastroesophageal Reflux, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- patients with GERD after LSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,537 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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'
Who cannot join
- Patients under the age of 16 or over 65,
- those with severe GERD,
- pregnancy, or
- inflammatory bowel disease,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- patients with GERD after LSG
- Keywords
- laparoscopic sleeve gastrectomy, morbid obesity, GERD
- Medical subject headings
- Gastroesophageal Reflux, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with GERD after LSGProcedure or surgery
Also called GERD after LSG
patients with GERD after LSG
| Study group | Role | What they receive |
|---|---|---|
| Patients in group I (G1) had GERD | Active comparator | Patients developed GERD after LSG Receives: Procedure: patients with GERD after LSG |
| Patients in group I (G2) had no GERD | Active comparator | Patients not developed GERD after LSG Receives: Procedure: patients with GERD after LSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one month
Secondary outcomes (2)
Gastropexy
YES (WITH GASTROPEXY) OR NO (WITHOUT GASTROPEXY) .....RISK FACTORS AND PROTECTIVE FACTORS for GERD
Measured: one month
smoking
YES (WITH SMOKING) OR NO (WITHOUT SMOKING)......RISK FACTORS AND PROTECTIVE FACTORS for GERD
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startJan 2017
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- Ayman El E Nakeeb, Principal investigator, Mansoura University, Gastrointestinal Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416645
- Sponsor's protocol ID
- LSG
- Acronym
- LSG-GERD
- Status last verified
- Jan 2022
- First submitted
- 6 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study protocol will be available for another researcher
Publications
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.
PubMed 35596915Chue 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.
PubMed 35445323Pavone 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 35432994Sancho 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.
PubMed 35048247El 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.
PubMed 36087223
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Predictors, and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy Multicentric Cohort Study
- ClinicalTrials.gov ID
- NCT05416645
- Acronym / sponsor ID
- LSG-GERD / LSG
- Conditions
- Gastroesophageal Reflux
- Keywords
- laparoscopic sleeve gastrectomy, morbid obesity, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients in group I (G1) had GERD | Active comparator | Procedure: patients with GERD after LSGPatients developed GERD after LSG |
| Patients in group I (G2) had no GERD | Active comparator | Procedure: patients with GERD after LSGPatients not developed GERD after LSG |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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'
Key exclusion criteria (4 listed)
- Patients under the age of 16 or over 65,
- those with severe GERD,
- pregnancy, or
- inflammatory bowel disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with GERD after LSGAlso: GERD after LSGpatients with GERD after LSG | Procedure or surgery | Patients in group I (G1) had GERD, Patients in group I (G2) had no GERD |
Primary outcome
GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire
Time frame: one month
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)
2 secondary outcomes
Gastropexy
Time frame: one month
smoking
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Results publication: PubMed 35596915Emile 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 publication: PubMed 35445323Chue 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 publication: PubMed 35432994Pavone 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 publication: PubMed 35048247Sancho 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.
- Derived from this study: PubMed 36087223El 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.
- mansoura universityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. the study protocol will be available for another researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman El E Nakeeb principal investigator
Mansoura University, Gastrointestinal Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients with GERD after LSG in people with Gastroesophageal Reflux, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416645, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.