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

NCT ID: NCT03493620

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2020-08-01

Brief 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Device arm

Gastric endosuturing will be performed until the entire gastric body is sutured in the form of a tube.

Group Type: EXPERIMENTAL

Device arm

Intervention Type: PROCEDURE

Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.

Sham arm

Group II is a control group (only the endoscopist will know which group each patient belongs to)

Group Type: SHAM_COMPARATOR

Sham arm

Intervention Type: PROCEDURE

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.

Interventions

Device arm

Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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 Gustavo de Quadros, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Clinica and Day Hospital

Eduardo Grecco, MD

Role: PRINCIPAL_INVESTIGATOR

ABC Medical School

Manoel Galvao Neto, MD

Role: PRINCIPAL_INVESTIGATOR

ABC Medical School

Thiago Ferreira de Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

ABC Medical School

Locations

Faculty of Medicine of ABC

Santo André, São Paulo, Brazil

Kaiser Clinic and Day Hospital

São José do Rio Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ApolloSham

Identifier Type: -

Identifier Source: org_study_id