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

Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Endoscopic gastroplasty

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo André, SP, Brazil, 09190-615
      • Mario Covas Hospital
    • Sao Jose do Rio Preto, SP, Brazil
      • Kaiser Day hospital
    • Sao Paulo, SP, Brazil, 01409-002
      • 9 de Julho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endoscopic gastroplasty; Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.	Procedure: Endoscopic gastroplasty; Vertical endoscopic gastroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood count	Measured in cmm	48 weeks
Hb1AC	Measured in percentage	48 weeks
Cholesterol	Measured in mg/dL	48 weeks
Fasting blood glucose	Measured in mg/dL	48 weeks
Procedural complications	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.	At the time of procedure and at 6 months and 1 year follow-up period

Collaborators and Investigators

• Sponsor: Kaiser Clinic and Hospital
• Investigators: Principal Investigator: Luiz Guatavo de Quadros, MD, Kaiser Clinica and Day Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1854540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No