obesity patients with BMI more than 27kg/m2 Obesity, Endoscopic therapy, Bariatric surgery
Conditions
Interventions
Endoscopic Sleeve Gastroplasty will be done using an endoscopic suturing device
Endoscopic therapy, Bariatric surgery, Obesity,
Sponsors
Sumiyama Kazuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) BMI of 27 kg/m2 or more. 2) A patient who has diabetes mellitus, hypertension, disorder of lipid metabolism, hepatic dysfunction or sleep apnea syndrome. 3) A patient who are aged of 20 years or older and 65 years or younger at giving their consent. 4) A patient who can understand this clinical trial and the informed concent can be obained with free will by the patient. 5) A patient who have already followed up for three months and can come to Jikei university l according to the planned schedule 6) A Japanese patient
Exclusion criteria
Exclusion criteria: Primary: depends on interview 1) A patent who can't stop antithrombotic or anticoagulant drug 2) A patient who is pregnant or who is probably pregnant 3) A patient who is nursing 4) A patient who has experience of undergoing upper abdominal surgery with possible perigastric adhesions 5) Prader-Willi syndrome 6) A patient who is evaluated as an inappropriate patient by clinical researchers Secondary: depends on examinations 7) Serum creatinine > 1.5mg/dl 8) A patient who has malignancy 9) A patient who has active gastric ulcer 10) A patient who is/was infected by Helicobacter pylori 11) A patient who has chronic gastritis 12) A patient who has esophageal/ gastric varices 13) A patient who is evaluated as an inappropriate patient by clinical researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A rate of adverse event associated with Endoscopic Sleeve Gastroplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percent of total body weight loss = (weight before ESG- weight after ESG)/ weight before ESGX100 2) A change of waist circumference 3) A change of blood biochemistry test and blood pressure 4) A change of mediations for diabetes mellitus, hyperlipidemia, and hypertension 5) A change of nutrient intake 6) A change of intestinal microbiota 7) A change of oral flora | — |
Contacts
Public ContactAkira Dobashi
The Jikei University School of Medicine
Outcome results
None listed