Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study

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ClinicalTrials.gov Identifier: NCT00821197

Recruitment Status : Active, not recruiting

First Posted : January 13, 2009

Last Update Posted : January 28, 2020

Sponsor:

Collaborator:

The Hospital of Vestfold

Information provided by (Responsible Party):

Tom Mala, Oslo University Hospital

Study Description

Brief Summary:

The main study objective:

To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. "distal" gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2).

The main study hypothesis:

Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Condition or disease	Intervention/treatment	Phase
Obesity	Procedure: long-limb gastric bypass Procedure: distal gastric bypass	Not Applicable

Detailed Description:

Technical data will later be published in detail

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	115 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study
Study Start Date :	February 2011
Actual Primary Completion Date :	May 2015
Estimated Study Completion Date :	May 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: long-limb bypass Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)	Procedure: long-limb gastric bypass Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Active Comparator: Distal gastric bypass Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)	Procedure: distal gastric bypass Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Outcome Measures

Primary Outcome Measures :

Primary outcome: weight loss [ Time Frame: 2 years postoperatively ]
physical examination

Secondary Outcome Measures :

Secondary outcome: Quality of life [ Time Frame: 2 years postoperative ]
questionnaire
Adverse events [ Time Frame: 2 years postoperative ]
medical history, journals
Number of patients with vitamin deficiencies [ Time Frame: 2 years postoperative ]
Blood samples
Number of patients with mineral deficiencies [ Time Frame: 2 years postoperative ]
Blood samples
Number of participants with malnutrition [ Time Frame: 2 years postoperative ]
Blood samples
Weight loss 5 year [ Time Frame: 5 year postoperative ]
physical examination
Health related Quality of life [ Time Frame: 5 years postoperative ]
questionnaire
Number of patients with malnutrition [ Time Frame: 5 years postoperative ]
Blood samples
Number of patients with mineral deficiencies [ Time Frame: 5 years postoperative ]
Blood samples
Number of patients with vitamin deficiencies [ Time Frame: 5 years postoperative ]
Blood samples
Adverse events [ Time Frame: 5 years ]
Medical history, journals
Weight loss 10 years [ Time Frame: 10 years postoperative ]
Weight measure
Adverse events [ Time Frame: 10 years postoperative ]
Medical history, journals
Number of patients with malnutrition [ Time Frame: 10 years postoperative ]
Blood samples
Number of patients with mineral deficiencies [ Time Frame: 10 years postoperative ]
Blood samples
Number of patients with vitamin deficiencies [ Time Frame: 10 years postoperative ]
Blood samples
Health related Quality of life [ Time Frame: 10 years postoperative ]
questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery
BMI 48 - 62 kg/m2 at study inclusion
informed consent
scheduled for bariatric surgery

Exclusion Criteria:

previous bariatric surgery
previous major abdominal surgery
previous history or established urolithiasis
viral hepatitis, liver cirrhosis of any kind
factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821197

Locations

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Norway
Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Oslo, Norway, 0514

Sponsors and Collaborators

Oslo University Hospital

The Hospital of Vestfold

Investigators

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Study Chair:	Tom Mala MD, PhD Rune Sandbu, MD, PhD	Aker University Hospital / The Hospital of Vestfold

More Information

Additional Information:

hospital site This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Svanevik M, Risstad H, Hofsø D, Blom-Høgestøl IK, Kristinsson JA, Sandbu R, Småstuen MC, Thorsby PM, Mala T, Hjelmesæth J. Bone Turnover Markers After Standard and Distal Roux-en-Y Gastric Bypass: Results from a Randomized Controlled Trial. Obes Surg. 2019 Sep;29(9):2886-2895. doi: 10.1007/s11695-019-03909-1.

Svanevik M, Risstad H, Karlsen TI, Kristinsson JA, Småstuen MC, Kolotkin RL, Søvik TT, Sandbu R, Mala T, Hjelmesæth J. Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial. Obes Surg. 2018 Mar;28(3):606-614. doi: 10.1007/s11695-017-2891-3.

Risstad H, Svanevik M, Kristinsson JA, Hjelmesæth J, Aasheim ET, Hofsø D, Søvik TT, Karlsen TI, Fagerland MW, Sandbu R, Mala T. Standard vs Distal Roux-en-Y Gastric Bypass in Patients With Body Mass Index 50 to 60: A Double-blind, Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1146-1155. doi: 10.1001/jamasurg.2016.2798.

Svanevik M, Risstad H, Hofsø D, Schou CF, Solheim B, Søvik TT, Kristinsson J, Hjelmesæth J, Mala T, Sandbu R. Perioperative Outcomes of Proximal and Distal Gastric Bypass in Patients with BMI Ranged 50-60 kg/m(2)--A Double-Blind, Randomized Controlled Trial. Obes Surg. 2015 Oct;25(10):1788-95. doi: 10.1007/s11695-015-1621-y.

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Responsible Party:	Tom Mala, Principal investigator Surgeon phd Tom Mala Rune Sandbu, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00821197
Other Study ID Numbers:	AT-0910-ST
First Posted:	January 13, 2009 Key Record Dates
Last Update Posted:	January 28, 2020
Last Verified:	January 2020

Keywords provided by Tom Mala, Oslo University Hospital:


obesity laparoscopy bariatric super obesity

Additional relevant MeSH terms:

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Obesity Overnutrition Nutrition Disorders Overweight Body Weight

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