Evaluating the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Obesity.

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Endoscopic gastroplasty

• Registration Number: NCT03088332
• Lead Sponsor: Kaiser Clinic and Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Study Start: 2017-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• BMI > 30 and < 36 with or without comorbidities
• BMI > 36 and < 40 without comorbidities

Exclusion Criteria

• Prior gastric surgery
• Use of anticoagulants
• Psychiatric disorders
• Severe esophagitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic gastroplasty	Endoscopic gastroplasty	Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.

Primary Outcome Measures

Name	Time	Method
Weight loss	48 weeks	Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared

Secondary Outcome Measures

Name	Time	Method
Hb1AC	48 weeks	Measured in percentage
Fasting blood glucose	48 weeks	Measured in mg/dL
Procedural complications	At the time of procedure and at 6 months and 1 year follow-up period	Complications related to the procedure, either at the time of the procedure (bleeding, perforation and suture rupture) or in the postoperative period, performing an endoscopy at 6 months and 1 year to evaluate the suture line.
Cholesterol	48 weeks	Measured in mg/dL
Blood count	48 weeks	Measured in cmm

Trial Locations

Locations (3)

Mario Covas Hospital; 🇧🇷 Santo André, SP, Brazil

Kaiser Day hospital; 🇧🇷 Sao Jose do Rio Preto, SP, Brazil

9 de Julho Hospital; 🇧🇷 Sao Paulo, SP, Brazil