Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03493620 |
| Other study ID # |
ApolloSham |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2018 |
| Est. completion date |
August 1, 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 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.
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.
