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

• Sponsor: Kaiser Clinic and Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03088332
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Actual Duration (Months): 43
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Endoscopic gastroplasty	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Weight loss [48 weeks]

   Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared

Secondary Outcome Measures

1. Blood count [48 weeks]

   Measured in cmm

2. Hb1AC [48 weeks]

   Measured in percentage

3. Cholesterol [48 weeks]

   Measured in mg/dL

4. Fasting blood glucose [48 weeks]

   Measured in mg/dL

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mario Covas Hospital	Santo André	SP	Brazil	09190-615
2	Kaiser Day hospital	Sao Jose do Rio Preto	SP	Brazil
3	9 de Julho Hospital	Sao Paulo	SP	Brazil	01409-002

Sponsors and Collaborators

• Kaiser Clinic and Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Clinic and Hospital
• ClinicalTrials.gov Identifier: NCT03088332
• Other Study ID Numbers: 1854540
• First Posted: Mar 23, 2017
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Aug 17, 2022