NCT01986816

Brief Summary

The purpose of this study is to investigate the cost of treatment and adverse efffects therof corresponds to quality of life improvements and expected wheightloss.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 11, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

November 11, 2013

Last Update Submit

February 12, 2019

Conditions

Obesity

Keywords

ObesityBariatric surgeryLaparoscopic gastric bypassQuality of lifeQALY

Outcome Measures

Primary Outcomes (1)

  • Significant wheigtloss

    1 year

Secondary Outcomes (1)

  • Quality of life improvement

    3 months and 12 months post surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Populutaion af morbid obese patients with BMI of 35 or more eligible for bariatric surgery

You may qualify if:

  • BMI \> 35
  • age 18-60 years

You may not qualify if:

  • Prior bariatric surgery
  • Prior gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalmar County Hospital

Kalmar, Kalmar County, 391 85, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

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

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 19, 2013

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

SE(1)