Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
NCT ID: NCT04284943
Last Updated: 2023-07-05
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
NA
120 participants
INTERVENTIONAL
2020-12-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Long limb Roux-en-Y reconstruction
Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Long limb Roux-en-Y reconstruction after subtotal gastrectomy
The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
Conventional Roux-en-Y reconstruction
Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer.
Conventional Roux-en-Y reconstruction after subtotal gastrectomy
The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
Billroth II reconstruction
Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer
Billroth II reconstruction after subtotal gastrectomy
The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
Interventions
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Long limb Roux-en-Y reconstruction after subtotal gastrectomy
The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
Conventional Roux-en-Y reconstruction after subtotal gastrectomy
The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
Billroth II reconstruction after subtotal gastrectomy
The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 23 kg/m2
* Type 2 diabetes and HbA1c ≥ 6.5%
Exclusion Criteria
* Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
* Abdominal, thoracic, pelvic and/or obstetric-gynecologic surgery within 3 months
* Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible
* Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease
* Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency
* Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders
* Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months
* Severe pulmonary disease defined as FEV1 \<50% of predicted value
* Anemia defined as hemoglobin less than 8 in females and 10 in males
* Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion
* Frail elderly (Rockwood Clinical Frailty Scale ≥5)
* Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
* Unable to understand the risks, realistic benefits and compliance requirements of each program
* Use of investigational therapy or participation in any other clinical trial within 3 months
* Geographic inaccessibility
* Pregnancy
20 Years
69 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
The First Hospital of Jilin University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Korea University Ansan Hospital
OTHER
Korea University Anam Hospital
OTHER
Responsible Party
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Sungsoo Park
Professor
Principal Investigators
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Sungsoo Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STARDOM
Identifier Type: -
Identifier Source: org_study_id
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