Gastroesophageal Reflux DiseaseNCT05405816
Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter
A study testing laparoscopic sleeve gastrectomy in people with Gastroesophageal Reflux Disease and Obesity, Morbid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
710 / 5.000 Çeviri sonuçları Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The overall relationship between sleeve gastrectomy and gastroesophageal reflux disease is still unclear. Only acid reflux can be detected in the esophagus with a standard 24-hour pH-meter. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Obesity, Morbid
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older and younger than 65 years.
- At least 5 years of morbid obesity (BMI >40 or >35 and comorbidity)
- Patients with transient or inadequate response weight loss despite dieting under the guidance of a dietitian.
Who cannot join
- Past upper gastrointestinal surgery,
- Paraesophageal (type 2), mixed (type 3), or sliding hiatal hernias of 3 cm or more,
- Patients with esophagitis and/or Barrett's metaplasia on upper GI endoscopy
- Those with peripheral vascular disease Those with a history of cerebrovascular accident
- Patients with coagulopathy
- History of chronic analgesic use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih sultan mehmet training and research hospital
Istanbul, 34734
About this study
Official title: Determination of the Change in Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy by 24-hour Multichannel Intraluminal Impedance and pH Test
710 / 5.000 Çeviri sonuçları Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The overall relationship between sleeve gastrectomy and gastroesophageal reflux disease is still unclear. Only acid reflux can be detected in the esophagus with a standard 24-hour pH-meter. A 24-hour pH-meter is normal in 30-50% of patients with nonerosive reflux. Impedance-pH meter, on the other hand, is a newly developed technique and determines all kinds of reflux (gas, liquid, acid and non-acid), the level of reflux and the clearance time of the esophagus. This prospective series aims to examine the relationship between LSG operation and esophago-gastric physiology using intraluminal impedance testing before and after LSG operation.
Read the detailed description
Power analysis, Tien Yew Chern et al. (1) was based on the study conducted by As a result of the Power analysis using the G*Power program, when the effect size d (effect size): 0.834 and SD: 38.6 were taken for the reflux episode parameter, the minimum number of samples determined for Power: 0.90 and α: 0.05 was determined as n=18. Considering the data losses, the number of patients was planned as 38. A total of 20 patients were evaluated at the end of the study.
Patients over the age of 18 and younger than 64, with at least 5 years of morbid obesity (BMI >40 or >35 comorbidity), temporary or inadequate response weight loss despite dietetic-guided diet, who underwent laparoscopic sleeve gastrectomy in our clinic and wished to be included in the study were included in the study.
All patients' pre- and postoperative age, gender, weight, body mass index, comorbidities recorded in an excel file. Symptoms The F-scale for the frequency and intensity of pre- and post-operative esophageal symptoms (such as heartburn, regurgitation, epigastric pain, and bloating) will be routinely applied to patients 1 month before and 3 months after surgery. Preoperative esophagogastroscopy, which is routinely applied to all patients in our clinic, will continue to be routinely performed in the 1st month preoperatively . Esophagogastroscopy will be performed under sedation in all patients. In addition, preoperative upper abdomen USG will be performed on patients to reveal the etiology of reflux.
Twenty-four hour ambulatory combined pH-multichannel intraluminal impedance studies will be performed to document the presence of gastroesophageal reflux disease with a combined 24-Hour Multichannel Intraluminal Impedance and pHmeter. Abnormal total acid and non-acid exposure will be defined according to the 2004 consensus of Sifrim D. et al. (Gastroesophageal reflux monitoring: Review and consensus report on detection and definitions of acid, non-acid and gasreflux) (2). Patients' demeester score will be calculated routinely before and after surgery. In our study, investigators aimed to determine the preoperative and postoperative gastroesophageal disease findings of the patients by impedance, so the patients were not divided into different study groups. The diagnosis of GERD was made according to the Lyon consensus and the Update Porto consensus(3,4).The result of the impedance procedure applied to the patient will be evaluated when the study is completed. Due to the double-blind nature of the study, the outcome of the impedance procedure will not be known to the surgeon, researcher and patient who will perform the operation until the end of the study. Only the physician who performed the impedance procedure will know the result of the impedance procedure.
- Conditions
- Gastroesophageal Reflux Disease, Obesity, Morbid
- Being tested
- laparoscopic sleeve gastrectomy
- Keywords
- laparoscopic sleeve gastrectomy, Gastroesophageal reflux disease, Impedance-pH meter
- 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.
laparoscopic sleeve gastrectomyProcedure or surgery
laparoscopic sleeve gastrectomy for obesity
| Study group | Role | What they receive |
|---|---|---|
| after laparoscopic sleeve gastrectomy | Other | Patients who underwent laparoscopic sleeve gastrectomy surgery Receives: Procedure: laparoscopic sleeve gastrectomy |
| before laparoscopic sleeve gastrectomy surgery | No intervention | obese patient preparing for laparoscopic sleeve gastrectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour multi-channel impedance ph-meter
Detection of reflux with 24-hour multi-channel impedance pH-meter
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Measurement of the change in gastroesophageal reflux disease after laparoscopic sleeve gastrectomy with 24-hour multichannel intraluminal impedance and pH-meter. It is aimed to determine the effect of surgery in a single group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Teke, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405816
- Sponsor's protocol ID
- emreteke
- Status last verified
- Feb 2023
- First submitted
- 30 May 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chern TY, Chan DL, Maani J, Ferguson JS, Talbot ML. High-resolution impedance manometry and 24-hour multichannel intraluminal impedance with pH testing before and after sleeve gastrectomy: de novo reflux in a prospective series. Surg Obes Relat Dis. 2021 Feb;17(2):329-337. doi: 10.1016/j.soard.2020.09.030. Epub 2020 Sep 23.
PubMed 33153961Sifrim D, Castell D, Dent J, Kahrilas PJ. Gastro-oesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux. Gut. 2004 Jul;53(7):1024-31. doi: 10.1136/gut.2003.033290.
PubMed 15194656Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
PubMed 29437910Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.
PubMed 28370768
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Change in Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy by 24-hour Multichannel Intraluminal Impedance and pH Test
- ClinicalTrials.gov ID
- NCT05405816
- Acronym / sponsor ID
- emreteke
- Conditions
- Gastroesophageal Reflux Disease, Obesity, Morbid
- Keywords
- laparoscopic sleeve gastrectomy, Gastroesophageal reflux disease, Impedance-pH meter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 6 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.
710 / 5.000 Çeviri sonuçları Laparoscopic sleeve gastrectomy (LSG) has become the most common bariatric procedure in obesity. The overall relationship between sleeve gastrectomy and gastroesophageal reflux disease is still unclear. Only acid reflux can be detected in the esophagus with a standard 24-hour pH-meter. A 24-hour pH-meter is normal in 30-50% of patients with nonerosive reflux. Impedance-pH meter, on the other hand, is a newly developed technique and determines all kinds of reflux (gas, liquid, acid and non-acid), the level of reflux and the clearance time of the esophagus. This prospective series aims to examine the relationship between LSG operation and esophago-gastric physiology using intraluminal impedance testing before and after LSG operation.
Detailed description
Power analysis, Tien Yew Chern et al. (1) was based on the study conducted by As a result of the Power analysis using the G*Power program, when the effect size d (effect size): 0.834 and SD: 38.6 were taken for the reflux episode parameter, the minimum number of samples determined for Power: 0.90 and α: 0.05 was determined as n=18. Considering the data losses, the number of patients was planned as 38. A total of 20 patients were evaluated at the end of the study.
Patients over the age of 18 and younger than 64, with at least 5 years of morbid obesity (BMI >40 or >35 comorbidity), temporary or inadequate response weight loss despite dietetic-guided diet, who underwent laparoscopic sleeve gastrectomy in our clinic and wished to be included in the study were included in the study.
All patients' pre- and postoperative age, gender, weight, body mass index, comorbidities recorded in an excel file. Symptoms The F-scale for the frequency and intensity of pre- and post-operative esophageal symptoms (such as heartburn, regurgitation, epigastric pain, and bloating) will be routinely applied to patients 1 month before and 3 months after surgery. Preoperative esophagogastroscopy, which is routinely applied to all patients in our clinic, will continue to be routinely performed in the 1st month preoperatively . Esophagogastroscopy will be performed under sedation in all patients. In addition, preoperative upper abdomen USG will be performed on patients to reveal the etiology of reflux.
Twenty-four hour ambulatory combined pH-multichannel intraluminal impedance studies will be performed to document the presence of gastroesophageal reflux disease with a combined 24-Hour Multichannel Intraluminal Impedance and pHmeter. Abnormal total acid and non-acid exposure will be defined according to the 2004 consensus of Sifrim D. et al. (Gastroesophageal reflux monitoring: Review and consensus report on detection and definitions of acid, non-acid and gasreflux) (2). Patients' demeester score will be calculated routinely before and after surgery. In our study, investigators aimed to determine the preoperative and postoperative gastroesophageal disease findings of the patients by impedance, so the patients were not divided into different study groups. The diagnosis of GERD was made according to the Lyon consensus and the Update Porto consensus(3,4).The result of the impedance procedure applied to the patient will be evaluated when the study is completed. Due to the double-blind nature of the study, the outcome of the impedance procedure will not be known to the surgeon, researcher and patient who will perform the operation until the end of the study. Only the physician who performed the impedance procedure will know the result of the impedance procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Measurement of the change in gastroesophageal reflux disease after laparoscopic sleeve gastrectomy with 24-hour multichannel intraluminal impedance and pH-meter. It is aimed to determine the effect of surgery in a single group.
| Arm | Type | Receives |
|---|---|---|
| after laparoscopic sleeve gastrectomy | Other | Procedure: laparoscopic sleeve gastrectomyPatients who underwent laparoscopic sleeve gastrectomy surgery |
| before laparoscopic sleeve gastrectomy surgery | No intervention | –obese patient preparing for laparoscopic sleeve gastrectomy surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older and younger than 65 years.
- At least 5 years of morbid obesity (BMI >40 or >35 and comorbidity)
- Patients with transient or inadequate response weight loss despite dieting under the guidance of a dietitian.
Key exclusion criteria (6 listed)
- Past upper gastrointestinal surgery,
- Paraesophageal (type 2), mixed (type 3), or sliding hiatal hernias of 3 cm or more,
- Patients with esophagitis and/or Barrett's metaplasia on upper GI endoscopy
- Those with peripheral vascular disease Those with a history of cerebrovascular accident
- Patients with coagulopathy
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 |
|---|---|---|
| laparoscopic sleeve gastrectomylaparoscopic sleeve gastrectomy for obesity | Procedure or surgery | after laparoscopic sleeve gastrectomy |
Primary outcome
24-hour multi-channel impedance ph-meter
Time frame: 4 months
Detection of reflux with 24-hour multi-channel impedance pH-meter
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 13 Feb 2023.
- Background: PubMed 33153961Chern TY, Chan DL, Maani J, Ferguson JS, Talbot ML. High-resolution impedance manometry and 24-hour multichannel intraluminal impedance with pH testing before and after sleeve gastrectomy: de novo reflux in a prospective series. Surg Obes Relat Dis. 2021 Feb;17(2):329-337. doi: 10.1016/j.soard.2020.09.030. Epub 2020 Sep 23.
- Background: PubMed 15194656Sifrim D, Castell D, Dent J, Kahrilas PJ. Gastro-oesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux. Gut. 2004 Jul;53(7):1024-31. doi: 10.1136/gut.2003.033290.
- Background: PubMed 29437910Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
- Background: PubMed 28370768Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy in people with Gastroesophageal Reflux Disease and Obesity, Morbid, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 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 13 Feb 2023. 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 Turkey (Türkiye). 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?
24-hour multi-channel impedance ph-meter (time frame: 4 months). 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 NCT05405816, which also lists 4 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 13 Feb 2023.