Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Device arm; Procedure: Sham arm

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo André, SP, Brazil
      • FACULTY OF MEDICINE OF ABC
    • São José Do Rio Preto, SP, Brazil
      • Kaiser Clinic and Day 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:

• Aged over 18 years,
• BMI > 30 and < 36 kg/m2, with or without comorbidities,
• BMI > 36 and < 40 without comorbidities

Exclusion Criteria:

• Previous gastric surgery
• Taking anticoagulant drugs
• Psychiatric disorders
• Severe esophagitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device arm; Gastric endosuturing will be performed until the entire gastric body is sutured in the form of a tube.	Procedure: Device arm; Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.
Sham Comparator: Sham arm; Group II is a control group (only the endoscopist will know which group each patient belongs to)	Procedure: Sham arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	weight in kg	outcome will be evaluated for 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight maintenance	weight in kg	2 years
Surgical related complications		2 years
Comorbidities		2 years

Collaborators and Investigators

• Sponsor: Kaiser Clinic and Hospital
• Investigators: Principal Investigator: Eduardo Grecco, MD, ABC Medical School; Principal Investigator: Manoel Galvao Neto, MD, ABC Medical School; Principal Investigator: Thiago Ferreira de Souza, PhD, ABC Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

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: ApolloSham

Drug and device information, study documents

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