Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around
      the world in recent years. Treatment for patients with class III or class II obesity with
      comorbidities is already well established, with bariatric surgery being the best option.
      However, there is no consensus as to the best treatment for cases of class I and class II
      obesity without comorbidities. The objective of this research will be to make a gastric tube
      similar to that obtained in surgical gastroplication however it will be created using
      intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of
      the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same
      location.
    

Detailed description: 
      The objective of this research will be to make a gastric tube similar to that obtained in
      surgical gastroplication however it will be created using intragastric endoscopic sutures.
      The secondary objective will be to correlate demographic, endoscopic and laboratory data with
      the results of this procedure.

      Patients and Methods: Patients with class I obesity with or without comorbidities and
      patients with class II obesity without comorbidities, irrespective of gender and ethnic
      background, from the state of São Paulo and other states of the country will be submitted to
      vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service
      of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same
      location.

      Information will be obtained during the outpatient follow-up at the Hospital Mario Covas
      including demographic (gender, age), clinical (height, weight, time after procedure, systemic
      arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative
      data (complications).

      Preparation for the procedure: All the exams will be performed at the Hospital Mario Covas
      after the patients have fasted for at least 8 hours. The procedure will begin with the
      patient in left lateral decubitus under general anesthesia performed by an anesthesiologist.
      Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach
      is formed similar to a vertical gastrectomy.

      Recovery after the procedure: After the procedure and recovery from anesthesia, all patients
      will be discharged but only together with a companion. All patients will receive guidance and
      will remain in touch with a physician to report any adverse signs or symptoms.

      Outcomes Primary outcome: To confirm the efficacy of endoscopic sutures in the primary
      treatment of obesity.

      Secondary outcome: To evaluate the use of the endoscopic sutures in relation to demographic
      data.
    

Intervention name(s): Endoscopic gastroplasty
Intervention type(s): Procedure
Intervention description(s): Vertical endoscopic gastroplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment