Trial Outcomes & Findings for Gastric Procedures for Obesity (NCT NCT01026181)

NCT ID: NCT01026181

Last Updated: 2017-10-03

Results Overview

Change of body weight in Kilograms measured at follow-up visits two year after surgery

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: baseline to 2-year postoperation
• Results posted on: 2017-10-03

Participant Flow

Participant milestones

Measure	Laparoscopic Sleeve Gastrectomy Patient who had Laparoscopic Sleeve Gastrectomy for their morbid obesity	Laparoscopic Roux-en-Y Gastric Bypass Patients who had Laparoscopic Roux-en-Y Gastric Bypass for their morbid obesity	Laparoscopic Adjustable Gastric Banding Patients who had Laparoscopic Adjustable Gastric Banding for their morbid obesity
Overall Study STARTED	51	51	48
Overall Study COMPLETED	51	51	48
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gastric Procedures for Obesity

Baseline characteristics by cohort

Measure	LSG (Lap SG) n=51 Participants Laparoscopic Sleeve Gastrectomy	LRYGB n=51 Participants Laparoscopic Roux-en-Y Gastric Bypass	LAGB n=48 Participants Laparoscopic Adjustable Gastric Banding	Total n=150 Participants Total of all reporting groups
Age, Continuous	45.4 years STANDARD_DEVIATION 9.6 • n=5 Participants	41.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	43.1 years STANDARD_DEVIATION 10.3 • n=5 Participants	43.5 years STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	41 Participants n=7 Participants	45 Participants n=5 Participants	131 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized race · white race	46 Participants n=5 Participants	51 Participants n=7 Participants	44 Participants n=5 Participants	141 Participants n=4 Participants
Race/Ethnicity, Customized race · other race	5 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline to 2-year postoperation

Change of body weight in Kilograms measured at follow-up visits two year after surgery

Outcome measures

Measure	Laparoscopic Sleeve Gastrectomy n=51 Participants	Laparoscopic Roux-en-Y Gastric Bypass n=51 Participants	Laparoscopic Adjustable Gastric Banding n=48 Participants
Change in Body Weight	-21.4 kg Standard Deviation 16	-36.6 kg Standard Deviation 19.5	-7.0 kg Standard Deviation 9.7

PRIMARY outcome

Timeframe: from baseline to 2-year postoperation

Patients' weight and height were measured at follow up visit 2 years post operation.

BMI was calculated using the formula: weight (kg)/height(meter)^2

Outcome measures

Measure	Laparoscopic Sleeve Gastrectomy n=51 Participants	Laparoscopic Roux-en-Y Gastric Bypass n=51 Participants	Laparoscopic Adjustable Gastric Banding n=48 Participants
Change in BMI	-7.6 kg/m^2 Standard Deviation 5.7	-13.0 kg/m^2 Standard Deviation 6.6	-2.6 kg/m^2 Standard Deviation 3.5

Adverse Events

Laparoscopic Sleeve Gastrectomy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopic Roux-en-Y Gastric Bypass

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopic Adjustable Gastric Banding

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Laparoscopic Sleeve Gastrectomy n=51 participants at risk	Laparoscopic Roux-en-Y Gastric Bypass n=51 participants at risk	Laparoscopic Adjustable Gastric Banding n=48 participants at risk
Surgical and medical procedures gastrointestinal/staple line leak	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	3.9% 2/51 • Number of events 2 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures gastrointestinal/staple line bleed	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures anastamotic ulcer	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	5.9% 3/51 • Number of events 3 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures stricture	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures band slippage	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	12.5% 6/48 • Number of events 6 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures intraabdominal abscess	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	3.9% 2/51 • Number of events 2 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures hernia	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	7.8% 4/51 • Number of events 4 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.1% 1/48 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Surgical and medical procedures transfusion	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Renal and urinary disorders transient renal insufficiency	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Cardiac disorders NSTEMI/STEMI/arrhythmia	3.9% 2/51 • Number of events 2 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Vascular disorders intravenous hydration for hypovolemia	3.9% 2/51 • Number of events 2 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	17.6% 9/51 • Number of events 9 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.1% 1/48 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.
Respiratory, thoracic and mediastinal disorders pulmonary embolus	0.00% 0/51 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	2.0% 1/51 • Number of events 1 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.	0.00% 0/48 • 2 year after surgery. Adverse events were classified according to a modified Clavien-Dindo surgical complications system, focusing on grade III or higher. All reported adverse events required intervention, admission, or re-operation. Other non-serious adverse events were not collected/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Xinzhe Shi

Royal Alexandra Hospital

Phone: 7807356735

Email: xinzhe.shi@ahs.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place