Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A G Patel

ORCID ID

Contact details

Department of Surgery
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 7346 3065
ameet.patel@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116140810

Study information

Scientific title

Double-blind randomised controlled study to compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass in morbidly obese patients attending the Multidisciplinary Morbid Obesity Clinic at King's College Hospital

Acronym

Study hypothesis

1. To compare the early outcome (first six months post-operatively) of the two operations with that of a matched group of morbidly obese patients who are on a low calorie diet only (controls)
2. To determine if there is any clinical and statistical difference in the outcomes of the two surgical procedures in the early, medium and long term (up to 5 years post-operatively)

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Obesity

Intervention

T compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2003

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Kings College Hospital NHS Trust R&D Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D support funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/03/2016: No publications found, verifying study status with principal investigator.