Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03088332 |
| Other study ID # |
1854540 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
August 2022 |
| Source |
Kaiser Clinic and Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
