NCT01026181

Brief Summary

This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

October 3, 2017

Completed
Last Updated

October 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

December 3, 2009

Results QC Date

December 8, 2016

Last Update Submit

May 3, 2017

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in Body Weight

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

    baseline to 2-year postoperation

  • Change in BMI

    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

    from baseline to 2-year postoperation

Study Arms (3)

LSG

Laparoscopic Sleeve Gastrectomy

LRYGB

Laparoscopic Roux-en-Y Gastric Bypass

LAGB

Laparoscopic Adjustable Gastric Banding

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbidly obese patients aged from 18 to 65.

You may qualify if:

  • morbid obese patients aged from 18-65,
  • BMI \> 40 kg/m2 or BMI\> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.

You may not qualify if:

  • psychiatric illness,
  • substance abuse,
  • previous gastrointestinal surgery, and
  • any patient who transfers from laparoscopic to convention procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Xinzhe Shi
Organization
Royal Alexandra Hospital
xinzhe.shi@ahs.ca
7807356735

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc, MD, FRCSC

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 3, 2017

Results First Posted

October 3, 2017

Record last verified: 2017-05