ObesityPhase 3NCT00868543
Long or Very Long-Limb Gastric Bypass in Superobese
A Phase 3 study testing laparoscopic gastric Roux-en-Y gastric bypass in people with Obesity, run by Kaunas University of Medicine at 1 site in Lithuania.
Trial summary
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI>50) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- laparoscopic gastric Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- Jul 2008to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized male or female subjects 18-65 years of age.
- Obese subjects with body mass index (BMI= kg/m²)>50
- Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition.
- Patients who read the informed consent form and gave a written consent to participate in the study.
Who cannot join
- Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures.
- Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period.
- Pregnant women.
- Subjects taking immunosuppressive therapy.
- Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
Trial locations and contacts
1 site in 1 country.
Almantas Maleckas contact
Lithuania1 site, 1 recruiting
- Recruiting
KMUK, surgery department
Kaunas, 50009
Nerijus Kaselis, +37069943431, nkaselis@gmail.com
Nerijus Kaselis
About this study
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI>50) patients.
Read the detailed description
The study is a multicentre trial in which superobese (BMI>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol.
Approximate duration of subject participation
Subjects in the study will participate for approximately 5 years:
- Preoperative investigation and surgery 3- 5 days in the hospital;
- First follow up visit: 6 months after surgery;
- Next follow up visits: 12, 24, 36, 48 months after surgery;
- Last follow up visit: 5 years after surgery.
- The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.
- Conditions
- Obesity
- Being tested
- laparoscopic gastric Roux-en-Y gastric bypass
- Keywords
- Gastric bypass, obesity, superobese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic gastric Roux-en-Y gastric bypassProcedure or surgery
Also called laparoscopic gastric bypass
The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 150cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
laparoscopic gastric Roux-en-Y gastric bypassProcedure or surgery
Also called laparoscopic gastric bypass
The fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 250cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Long limb | Active comparator | Hospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with long (150 cm) alimentary Roux limb Receives: Procedure: laparoscopic gastric Roux-en-Y gastric bypass |
| Very long limb | Active comparator | Hospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with very long (250 cm) alimentary Roux limb Receives: Procedure: laparoscopic gastric Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
Measured: 7 years
Secondary outcomes (1)
To compare body mass index changes and absolute weight loss. To evaluate obesity-related medical problems. To obtain data about impromvement of metabolic syndrom. To compare quality of life changes between treatment arms.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Almantas Maleckas, Principal investigator, Kaunas University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868543
- Sponsor's protocol ID
- BE-2-37
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long or Very Long-Limb Gastric Bypass in Superobese
- ClinicalTrials.gov ID
- NCT00868543
- Acronym / sponsor ID
- BE-2-37
- Conditions
- Obesity
- Keywords
- Gastric bypass, obesity, superobese
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI>50) patients.
Detailed description
The study is a multicentre trial in which superobese (BMI>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol.
Approximate duration of subject participation
Subjects in the study will participate for approximately 5 years:
- Preoperative investigation and surgery 3- 5 days in the hospital;
- First follow up visit: 6 months after surgery;
- Next follow up visits: 12, 24, 36, 48 months after surgery;
- Last follow up visit: 5 years after surgery.
- The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long limb | Active comparator | Procedure: laparoscopic gastric Roux-en-Y gastric bypassHospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with long (150 cm) alimentary Roux limb |
| Very long limb | Active comparator | Procedure: laparoscopic gastric Roux-en-Y gastric bypassHospitalized male or female subjects 18-65 years of age,obese with body mass index (BMI= kg/m²)>50.Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition, who read the informed consent form and gave a written consent to participate in the study. Gastric bypass was performed with very long (250 cm) alimentary Roux limb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized male or female subjects 18-65 years of age.
- Obese subjects with body mass index (BMI= kg/m²)>50
- Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition.
- Patients who read the informed consent form and gave a written consent to participate in the study.
Key exclusion criteria (5 listed)
- Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures.
- Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period.
- Pregnant women.
- Subjects taking immunosuppressive therapy.
- Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic gastric Roux-en-Y gastric bypassAlso: laparoscopic gastric bypassThe fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 150cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis. | Procedure or surgery | Long limb |
| laparoscopic gastric Roux-en-Y gastric bypassAlso: laparoscopic gastric bypassThe fundus is separated by linear cutter. The intestine is opened approximately 75 cm from the ligament of Treitz and approached to the stomach. The gastrojejunostomy is performed in antecolic position The jejunum has to be in an antimesenteric position. After removing the endocutter, the anastomotic incision is closed with a continuous suture. The distance between the gastrojejunostomy and jejunojejunostomy was measured on the antimesenteric border with the bowel on a stretch. The jejunojejunostomy is performed in 250cm distance from gastrojejunostomy. The anastomosis is made by a posterior staple line and an anterior suture line. Preparation of a small window for the endocutter branches into the jejunal mesenterium 2-3 cm proximal to the gastrojejunostomy and above the entero-intestinal anastomosis. | Procedure or surgery | Very long limb |
Primary outcome
weight loss- we will compare percentage of excess body weight loss (%EWL) between groups.
Time frame: 7 years
1 secondary outcome
To compare body mass index changes and absolute weight loss. To evaluate obesity-related medical problems. To obtain data about impromvement of metabolic syndrom. To compare quality of life changes between treatment arms.
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almantas Maleckas contact
Almantas Maleckas principal investigator
Kaunas University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laparoscopic gastric Roux-en-Y gastric bypass in people with Obesity, run by Kaunas University of Medicine at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nerijus Kaselis (+37069943431, nkaselis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss- we will compare percentage of excess body weight loss (%EWL) between groups. (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.