Trial Outcomes & Findings for Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery (NCT NCT01754194)

NCT ID: NCT01754194

Last Updated: 2017-07-07

Results Overview

The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.

• Recruitment status: COMPLETED
• Target enrollment: 293 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2017-07-07

Participant Flow

293 adults were enrolled from 17 Mentor (performed at least 50 procedures) and Mentee (performed less than 50 procedures) bariatric German referral centres. They were stratified for laparoscopic sleeve gastrectomies and Roux en Y gastric bypass (ideally 50:50). First participant enrolled April 2012 Last participant enrolled October 2013.

Use or preference of surgical procedure was at the discretion of the surgeon. For each patient, the study consisted of three phases: Screening/Baseline; Surgery; Post-operative observation for up to 12 months. Data were gathered per SoC (Standard of Care) at each of the three study phases.

Participant milestones

Measure	Procedure Type 1 Gastric Sleeve Resection Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection	Procedure Type 2 Roux-en-Y Gastric Bypass Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass
Overall Study STARTED	169	124
Overall Study COMPLETED	117	97
Overall Study NOT COMPLETED	52	27

Reasons for withdrawal

Measure	Procedure Type 1 Gastric Sleeve Resection Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection	Procedure Type 2 Roux-en-Y Gastric Bypass Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass
Overall Study Lost to Follow-up	39	14
Overall Study Withdrawal by Subject	4	5
Overall Study Other	9	8

Baseline Characteristics

Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery

Baseline characteristics by cohort

Measure	Procedure Type 1 n=169 Participants Gastric Sleeve Resection Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection	Procedure Type 2 n=124 Participants Roux-en-Y Gastric Bypass Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass	Total n=293 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	169 Participants n=5 Participants	124 Participants n=7 Participants	293 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	96 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	28 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment Germany	169 participants n=5 Participants	124 participants n=7 Participants	293 participants n=5 Participants
Weight (Kgs)	140.8 Kgs STANDARD_DEVIATION 20.6 • n=5 Participants	132.3 Kgs STANDARD_DEVIATION 20.2 • n=7 Participants	137.2 Kgs STANDARD_DEVIATION 20.8 • n=5 Participants
Body Mass Index (kg/m^2)	47.6 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	45.8 kg/m^2 STANDARD_DEVIATION 5.0 • n=7 Participants	46.8 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants
Type of Insurance (Public/Private) Private Health Insurance	155 participants n=5 Participants	119 participants n=7 Participants	274 participants n=5 Participants
Type of Insurance (Public/Private) Public Health Insurance	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	3 Score*months Standard Deviation 0.1	3 Score*months Standard Deviation 0.1

PRIMARY outcome

Timeframe: 12 months

The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)	13 Score*months Standard Deviation 1.2	13 Score*months Standard Deviation 1.0

PRIMARY outcome

Timeframe: 12 months

The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)	45 Score*months Standard Deviation 8.2	47 Score*months Standard Deviation 5.8

SECONDARY outcome

Timeframe: 12 Months

EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.

The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] - IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight.

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Excess Weight Loss (EWL)	58 Percentage EWL*month Standard Deviation 2.3	58 Percentage EWL*month Standard Deviation 2.0

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Health Resource Utilization - Durantion of Sugery	83.2 Minutes Standard Deviation 33.5	135.9 Minutes Standard Deviation 51.0

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Health Resource Utilization - Recovery Time From Surgery	7.7 Days Standard Deviation 4.4	7.6 Days Standard Deviation 4.1

SECONDARY outcome

Timeframe: 12 Months

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization	50.9 percentage of patients	51.6 percentage of patients

SECONDARY outcome

Timeframe: 30 Days

Incidence of procedural and post-procedural complications through 30 days post-op.

Outcome measures

Measure	Procedure Type I n=169 Participants Gastric Sleeve Resection	Procedure Type II n=124 Participants Roux-en-Y Gastric Bypass
Surgical Complications Wound infection	7 participants	6 participants
Surgical Complications Disorder of emptying stomach/increased, new reflux	1 participants	6 participants
Surgical Complications Secondary haemorrhage, intra-abdominal	2 participants	4 participants
Surgical Complications Anastomotic leak	5 participants	1 participants
Surgical Complications Dumping syndrome	4 participants	2 participants
Surgical Complications Urinary tract infection	2 participants	2 participants
Surgical Complications Intra-abdominal abscess	3 participants	0 participants
Surgical Complications Diarrhoea	1 participants	2 participants
Surgical Complications Anastomotic stenosis	2 participants	0 participants
Surgical Complications Symptomatic cholelithiasis	2 participants	0 participants
Surgical Complications Others	9 participants	11 participants

Adverse Events

Procedure Type I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Procedure Type II

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

Maria Young - Clinical Research Manager

Medtronic MITG

Phone: +353 (0)1 4381611

Email: maria.young@medtronic.com

Results disclosure agreements

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