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

NCT05405816 | Completed

• 1 other identifier: emreteke
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Obesity, Morbid

Keywords

laparoscopic sleeve gastrectomy; Gastroesophageal reflux disease; Impedance-pH meter

Outcome Measures

Primary Outcomes (1)

• 24-hour multi-channel impedance ph-meter

  Detection of reflux with 24-hour multi-channel impedance pH-meter

  4 months

Study Arms (2)

after laparoscopic sleeve gastrectomy

OTHER

Patients who underwent laparoscopic sleeve gastrectomy surgery

Procedure: laparoscopic sleeve gastrectomy

before laparoscopic sleeve gastrectomy surgery

NO INTERVENTION

obese patient preparing for laparoscopic sleeve gastrectomy surgery

Interventions

laparoscopic sleeve gastrectomy PROCEDURE

laparoscopic sleeve gastrectomy for obesity

after laparoscopic sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih sultan mehmet training and research hospital

Istanbul, 34734, Turkey (Türkiye)

Location

Related 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.

  PMID: 33153961 BACKGROUND

• 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.

  PMID: 15194656 BACKGROUND

• 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.

  PMID: 29437910 BACKGROUND

• 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.

  PMID: 28370768 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity, Morbid

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Due to the double-blind nature of the study, the outcome of the impedance procedure will not be known by the surgeon and the patient until the end of the study. Only the researcher will know the result of the impedance process.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, assistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 6, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

TU (1)