4XL Study - Obesity Surgery in Adolescence (4XL)

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2015 by Sykehuset i Vestfold HF

Sponsor:

Collaborator:

The Hospital of Vestfold

Information provided by (Responsible Party):

Samira Lekhal, Sykehuset i Vestfold HF

ClinicalTrials.gov Identifier:

NCT00923819

First received: June 17, 2009

Last updated: November 16, 2015

Last verified: November 2015

History of Changes

Purpose

The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

Condition	Intervention
Obesity, Morbid	Procedure: Laparoscopic gastric bypass Behavioral: Standard conservative treatment


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	4XL-Study - Obesity Surgery in Adolescence

Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:

BMI [ Time Frame: Year 1, 2, 5, 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life (KINDL) [ Time Frame: Year ] [ Designated as safety issue: No ]
Recorded at baseline and after 1, 2, 5 and 10 years.
Eating Disorders (Child Eating Behavior Questionnaire) [ Time Frame: Year ] [ Designated as safety issue: No ]
Recorded at baseline and after 1, 2, 5 and 10 years.
Mental Health (Development and Well-Being Assessment, DAWBA) [ Time Frame: Year ] [ Designated as safety issue: No ]
Recorded at baseline and after 1, 2, 5 and 10 years.
Self-Esteem (Rosenberg Self-Esteem scale) [ Time Frame: Year ] [ Designated as safety issue: No ]
Recorded at baseline and after 1, 2, 5 and 10 years.
Surgical and Medical Complications [ Time Frame: Year ] [ Designated as safety issue: Yes ]
Recorded at baseline and after 1, 2, 5 and 10 years.
Blood sample results [ Time Frame: Year ] [ Designated as safety issue: No ]
Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.


Estimated Enrollment:	120
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2027
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Laparoscopic Gastric Bypass	Procedure: Laparoscopic gastric bypass Patients are referred to Morbid Obesity Center from other hospitals in Norway. The procedure will take place at the Hospital of Vestfold.
Active Comparator: Group B Standard conservative treatment	Behavioral: Standard conservative treatment The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month, either at the Morbid Obesity Center or a similar center in Norway.

Detailed Description:

The study has two intervention arms:

Experimental: Group A Surgery; laparoscopic gastric bypass

Active comparator: Group B Standard conservative treatment in a multidisiplinary team at Morbid Obesity Center

All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Hospital of Vestfold The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.

Eligibility


Ages Eligible for Study:	13 Years to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 13 and 18 years of age at inclusion
Tanner stage 4-5
BMI > 40 kg/m2 or BMI > 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor)
At least one year multidisciplinary treatment completed

Exclusion Criteria:

Tanner stage < 4
Substantial risk for lack of compliance
Obesity syndrome (e.g., Prader Willi syndrome)
Obesity related to brain damage
Serious general disease
Monogenic obesity

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923819

Contacts


Contact: Samira Lekhal, PhD,MD	+4741409191	samira.lekhal@siv.no
Contact: Jøran Hjelmesæth, MD, PhD	+4740217349	joran.hjelmeseth@siv.no

Locations


Norway
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority	Recruiting
Tønsberg, Norway, 3103
Principal Investigator: Samira Lekhal, MD, PhD

Sponsors and Collaborators

Sykehuset i Vestfold HF

The Hospital of Vestfold

Investigators


Principal Investigator:	Samira Lekhal, PhD,MD	Vestfold Hospital Trust/The Hospital of Vestfold
Study Chair:	Jøran Hjelmesæth, MD, PhD	Vestfold Hospital Trust/The Hospital of Vestfold

More Information


Responsible Party:	Samira Lekhal, PhD, MD, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:	NCT00923819 History of Changes
Other Study ID Numbers:	4XL-2009
Study First Received:	June 17, 2009
Last Updated:	November 16, 2015
Health Authority:	Norway: Ministry of Health and Care Services

Keywords provided by Sykehuset i Vestfold HF:


Adolescents Gastric Bypass Quality of Life Mental Health Lifestyle

Additional relevant MeSH terms:


Obesity Obesity, Morbid Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016

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