Trial Outcomes & Findings for Sonographic Evaluation of Visceral Fat After Bariatric Surgery (NCT NCT01285791)

Results Overview

morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .

Recruitment status

COMPLETED

Target enrollment

39 participants

Primary outcome timeframe

18 months

Results posted on

2016-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Undergoing Laparoscopic Adjustable Gastric Banding morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.	Patients Undergoing Laparoscopic Sleeve Gastrectomy morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased	Patients Undergoing Laparoscopic Gastric Bypass morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
Overall Study STARTED	11	15	13
Overall Study COMPLETED	11	15	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sonographic Evaluation of Visceral Fat After Bariatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Undergoing Laparoscopic Adjustable Gastric Banding n=11 Participants morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.	Patients Undergoing Laparoscopic Sleeve Gastrectomy n=15 Participants morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased	Patients Undergoing Laparoscopic Gastric Bypass n=13 Participants morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased	Total n=39 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 1.6 • n=5 Participants	36.5 years STANDARD_DEVIATION 3.1 • n=7 Participants	38.7 years STANDARD_DEVIATION 3 • n=5 Participants	37.9 years STANDARD_DEVIATION 1.6 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Israel	11 participants n=5 Participants	15 participants n=7 Participants	13 participants n=5 Participants	39 participants n=4 Participants

PRIMARY outcome

Timeframe: 18 months

morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .

Outcome measures

Outcome measures
Measure	Patients Undergoing Laparoscopic Adjustable Gastric Banding n=11 Participants morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.	Patients Undergoing Laparoscopic Sleeve Gastrectomy n=15 Participants morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased	Patients Undergoing Laparoscopic Gastric Bypass n=13 Participants morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.	3.6 visceral fat reduction in centimeters Standard Error 0.8	7.1 visceral fat reduction in centimeters Standard Error 0.5	5.6 visceral fat reduction in centimeters Standard Error 0.6

SECONDARY outcome

Timeframe: 18 months

finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.

Outcome measures

Outcome data not reported

Adverse Events

Patients Undergoing Laparoscopic Adjustable Gastric Banding

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Undergoing Laparoscopic Sleeve Gastrectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Undergoing Laparoscopic Gastric Bypass

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ido Mizrahi

Hadassah Medical Organization

Phone: +972-2-5844550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place