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

Primary Purpose

Gastroesophageal Reflux Disease, Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring laparoscopic sleeve gastrectomy, Gastroesophageal reflux disease, Impedance-pH meter

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fatih sultan mehmet training and research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

after laparoscopic sleeve gastrectomy

before laparoscopic sleeve gastrectomy surgery

Arm Description

Patients who underwent laparoscopic sleeve gastrectomy surgery

obese patient preparing for laparoscopic sleeve gastrectomy surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 30, 2022
Last Updated
February 10, 2023
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05405816
Brief Title
Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter
Official Title
Determination of the Change in Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy by 24-hour Multichannel Intraluminal Impedance and pH Test
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Obesity, Morbid
Keywords
laparoscopic sleeve gastrectomy, Gastroesophageal reflux disease, Impedance-pH meter

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
ParticipantCare Provider
Masking Description
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.
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
after laparoscopic sleeve gastrectomy
Arm Type
Other
Arm Description
Patients who underwent laparoscopic sleeve gastrectomy surgery
Arm Title
before laparoscopic sleeve gastrectomy surgery
Arm Type
No Intervention
Arm Description
obese patient preparing for laparoscopic sleeve gastrectomy surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Intervention Description
laparoscopic sleeve gastrectomy for obesity
Primary Outcome Measure Information:
Title
24-hour multi-channel impedance ph-meter
Description
Detection of reflux with 24-hour multi-channel impedance pH-meter
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fatih sultan mehmet training and research hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33153961
Citation
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.
Results Reference
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PubMed Identifier
15194656
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.
Results Reference
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PubMed Identifier
29437910
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.
Results Reference
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PubMed Identifier
28370768
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.
Results Reference
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Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter

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