Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486169
Other study ID # 2022/06/X/NZ5/00007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date August 31, 2023

Study information

Verified date January 2024
Source University of Warmia and Mazury in Olsztyn
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The planned research is to analyze the occurrence of gastroesophageal reflux disease (GERD) before and after sleeve gastrectomy (SG). The study includes patients with BMI above 40 kg / m2 without symptoms of GERD before surgery and any pathological changes in gastroscopy. The day before the surgery, patients will be tested with impedance pH measurement. Thereafter, patients will undergo SG according to standard technique. As part of the follow-up 6 months after the surgery, the pH-measurement test with impedance again will be performed again for evaluation of the occurrence of GERD after surgery. It was planned to include 50 people in the study. The main aim of the study is to assess the frequency and quality of GERD in patients after SG.


Description:

According to World Health Organization data, almost 15% of people in the world are obese, and this is constantly growing. According to the available literature, an effective method of observation long-term treatment that allows for the permanent cure of obesity is surgical treatment. Currently sleeve gastrectomy (SG) is the most commonly performed procedure in the world. There are numerous evidence of the effectiveness of surgery in treating obesity and comorbidities, however, came along with the increase in the number of procedures performed, controversy arises, including the occurrence of gastroesophageal reflux disease (GERD) after surgery. As a consequence, GERD can lead to esophageal cancer. This problem wants to be dealt with in this study. The planned research is to analyze the occurrence of GERD before and after SG. Down the study will include patients whose BMI is 40 kg / m2 and more who will be positive passed the qualification process for SG. The exclusion criteria are the occurrence of symptoms of GERD before surgery, pathological changes in gastroscopy - features of reflux oesophagitis, and the patient's lack of consent to participation in the study. On the eve of surgery, patients will be tested with impedance pH measurement. Is it non-invasive 24-hour examination consisting in measuring the pH and impedance of the esophagus allowing for the detection of reflux episodes and their accurate assessment - type, time. Currently this test is the gold standard for the diagnosis of GERD, including in patients asymptomatic. Thereafter, patients will undergo SG according to standard technique. As part of the follow-up 6 months after the surgery, the pH-measurement test with impedance again will be performed again for evaluation of the occurrence of GERD after surgery. It was planned to include 50 people in the study, which is good, satisfactory material for statistical analysis. The main aim of the study is to assess the frequency and quality of GERD in patients after SG. Yet published works on this issue define the occurrence of GERD mainly on on the basis of an interview with the patient or changes in the gastroscopy examination, which does not allow definitive definition of the disease incidence. Often, the mileage may be left to the patient asymptomatic - e.g. in the case of neutral reflux, and changes in endoscopic examination may not yet be visible. Thus, the only effective method to assess the occurrence of GERD is to perform a pH-measurement test with impedance. Moreover a group of 50 people subjected to the tests will make it possible to try to determine the predisposing factors to the occurrence of GERD after surgery, which will enable further the order of taking actions to prevent its occurrence. The results of the research will be presented on a thematic basis scientific conferences, then published in one of the renowned journals research in this field.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BMI above 40kg/m2 - positive qualification process for laparoscopic sleeve gastrectomy Exclusion Criteria: - symptoms of gastroesophageal reflux disease before the surgery - pathological changes in gastroscopy before the surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sleeve Gastrectomy
surgery of laparoscopic sleeve gastrectomy

Locations

Country Name City State
Poland UWM Olsztyn

Sponsors (2)

Lead Sponsor Collaborator
University of Warmia and Mazury in Olsztyn National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary gastroesophageal reflux after sleeve gastrectomy The main aim of the study is to assess the frequency and quality of gastroesophageal reflux disease in patients six months after sleeve gastrectomy. The reflux will be measured in each patient using 24-hour pH-impedance testing 6 months
Secondary outcomes of sleeve gastrectomy Each patient would have their body weight measured and asked about the resolution of comorbidities during the control visit six months after surgery 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2