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

NCT ID: NCT03088332

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic gastroplasty

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

Group Type: EXPERIMENTAL

Endoscopic gastroplasty

Intervention Type: PROCEDURE

Vertical endoscopic gastroplasty

Interventions

Endoscopic gastroplasty

Vertical endoscopic gastroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Clinic and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luiz Guatavo de Quadros, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Clinica and Day Hospital

Locations

Mario Covas Hospital

Santo André, São Paulo, Brazil

Kaiser Day hospital

São José do Rio Preto, São Paulo, Brazil

9 de Julho Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1854540

Identifier Type: -

Identifier Source: org_study_id