Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout
      the world in recent years. Bariatric surgery has been the most effective method for the
      treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the
      longevity and quality of life of patients. The treatment of patients with Class III obesity
      or higher or Class II with comorbidities is already well established with bariatric surgery
      being the best option. However, there is no consensus as to the best treatment in cases of
      Class I or II obesity without comorbidities. The objective of this research will be to make a
      gastric tube similar to that obtained by surgical gastroplication but using endoscopic
      intragastric sutures.
    

Detailed description: 
      The primary objective of this research will be to make a gastric tube similar to that
      obtained by surgical gastroplication but using endoscopic intragastric sutures. The secondary
      objective will be to correlate demographic, endoscopic and laboratory data with the outcomes.

      This study will be carried out in two institutions. The Kaiser Clinic and Day Hospital and
      the Faculty of Medicine of ABC. Sixty patients will be randomly selected for treatment by
      Endospore Endoscopy (ESG) or as controls (only the endoscopist will know which group each
      patient belongs to). The draw will take place only after upper endoscopy has been carried out
      to avoid possible contraindications for the procedure due to injuries. Once the criteria for
      endoscopic evaluation have been met, randomization will be carried out in loco with the
      patient still sedated. Gastric Endo Sutures will be performed when the patient is randomized
      for Group I; Group II will be the control group. All patients will be followed up for two
      years by a multidisciplinary team (endoscopist, surgeon, nutritionist and psychologist). The
      data will be obtained during the outpatient follow-up at the Hospital Mario Covas and will
      include demographic (gender, age), clinical (height, weight, BMI, time after procedure,
      hypertension, diabetes, dyslipidemia, smoking, alcoholism) and operative data
      (complications).

      Preparation to perform the examination/procedure: All exams will be performed with the
      patients within eight hours. The procedure will begin with the patient in left lateral
      decubitus position and under general anesthesia performed by an anesthesiologist. Endoscopic
      suturing will be performed with 2-0 prolene stitches until a tubular-shaped stomach is formed
      similar to vertical gastrectomy.

      Recovery after the procedure: After this procedure and recovery from the anesthesia, all
      patients will only be discharged in the company of a companion. All patients will be
      counseled to enter in touch with the physician to report any signs or symptoms.
    

Intervention name(s): Device arm; Sham arm
Intervention type(s): Procedure; Procedure
Intervention description(s): Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.; Group II will be conducted identically to Group I except for the procedure itself, and only the endoscopist, that is the researcher, will be aware of which group each patient belongs to.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment