Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 35.
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. will be.
All patients' pre- and postoperative age, gender, weight, body mass index, comorbidities and use of proton pump inhibitors or H2 receptor blockers will be 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 and postoperative esophagogastroscopy, which is routinely applied to all patients in our clinic, will continue to be routinely performed in the 1st month preoperatively and the 3rd month postoperatively. 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 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: after laparoscopic sleeve gastrectomy Patients who underwent laparoscopic sleeve gastrectomy surgery |
Procedure: laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy for obesity
|
| No Intervention: before laparoscopic sleeve gastrectomy surgery obese patient preparing for laparoscopic sleeve gastrectomy surgery |
Outcome Measures
Primary Outcome Measures
- 24-hour multi-channel impedance ph-meter [4 months]
Detection of reflux with 24-hour multi-channel impedance pH-meter
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years and older and younger than 65 years.
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At least 5 years of morbid obesity (BMI >40 or >35 and comorbidity)
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Patients with transient or inadequate response weight loss despite dieting under the guidance of a dietitian.
Exclusion Criteria:
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Past upper gastrointestinal surgery,
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Paraesophageal (type 2), mixed (type 3), or sliding hiatal hernias of 3 cm or more,
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Patients with esophagitis and/or Barrett's metaplasia on upper GI endoscopy
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Those with peripheral vascular disease Those with a history of cerebrovascular accident
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Patients with coagulopathy
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History of chronic analgesic use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fatih sultan mehmet training and research hospital | Istanbul | Turkey | 34734 |
Sponsors and Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- Sifrim 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. Review.
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