Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2008-07-31
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Long limb
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
laparoscopic gastric Roux-en-Y 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.
Very long limb
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
laparoscopic gastric Roux-en-Y 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.
Interventions
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laparoscopic gastric Roux-en-Y 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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Kaunas University of Medicine
OTHER
Responsible Party
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Kaunas University of Medicine
Principal Investigators
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Almantas Maleckas
Role: PRINCIPAL_INVESTIGATOR
Kaunas University of Medicine
Locations
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KMUK, surgery department
Kaunas, , Lithuania
Countries
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Central Contacts
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Almantas Maleckas
Role: CONTACT
Facility Contacts
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Other Identifiers
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BE-2-37
Identifier Type: -
Identifier Source: org_study_id
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