Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter

Obesity, Morbid Clinical Trial

Official title:

Determination of the Change in Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy by 24-hour Multichannel Intraluminal Impedance and pH Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405816
• Other study ID #: emreteke
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2023
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Obesity, Morbid

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy for obesity

Locations

Country	Name	City	State
Turkey	Fatih sultan mehmet training and research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Gyawali 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. — View Citation

Roman 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. — View Citation

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. doi: 10.1136/gut.2003.033290. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour multi-channel impedance ph-meter	Detection of reflux with 24-hour multi-channel impedance pH-meter	4 months