Determination of Change in Reflux Disease After Sleeve Gastrectomy by Intraluminal Impedance and pH-meter
Condition: Gastroesophageal Reflux Disease; Obesity, Morbid
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Obesity, Morbid
Study type: Interventional

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.
    

Intervention name(s): laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): laparoscopic sleeve gastrectomy for obesity
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention 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: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: laparoscopic sleeve gastrectomy; Gastroesophageal reflux disease; Impedance-pH meter