跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03938571
NCT03938571进行中（未招募）不适用

Torsby I Trial: A Prospectively Randomized Study on Standard Duodenal Switch vs. Single Anastomosis Duodeno-ileostomy Duodenal Switch

Värmland County Council, Sweden0 个研究点目标入组 56 人开始时间: 2016年8月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
56
主要终点
Change of weight (kg)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The aim of the Torsby I Trial is to identify differences and similarities between a standard duodenal switch (DS) and a single-anastomosis duodeno-ileostomy (SADI) regarding effect on weight, comorbidities and malnutrition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •BMI over 45
  • •Ability to understand the legal background of a study

排除标准

  • •Previous bariatric or anti-reflux surgery
  • •Drug-abuse
  • •Inflammatory bowel disease
  • •Complex psychiatric situation

研究组 & 干预措施

Standard DS

Experimental

Standard duodenal switch:

  1. Sleeve gastrectomy over a 35 Fr bougie
  2. Division of the duodenum 2-3 cm distally of the pylorus
  3. Measurement of the small bowel. 100 cm common channel. 150 cm alimentary limb.
  4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve.
  5. Entero-entero-anastomosis linear stapled and handsewn.
  6. Division between the two anastomosis.
  7. Closure of the mesenteric defects.

干预措施: Duodenal Switch (Procedure)

SADI-DS

Active Comparator

Duodenal switch with Single anastomosis duodeno-ileostomy:

  1. Sleeve gastrectomy over a 35 Fr bougie
  2. Division of the duodenum 2-3 cm distally of the pylorus
  3. Measurement of the small bowel. 250 cm alimentary limb/common channel.
  4. Duodenoileostomy completely handsewn with 250 cm distance to the ileocecal valve.
  5. Closure of the mesenteric defects.

干预措施: Duodenal Switch (Procedure)

结局指标

主要结局

Change of weight (kg)

时间窗: January 2024 (5 yr follow-up) and january 2029 (10 yr follow-up)

Change of weight in kg with calculation of the relative weight-loss under the follow-up

Early complications

时间窗: Up to 10 years after operation

Rate of minor and major complications

次要结局

  • Alterations in comorbidities (hypertension)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (diabetes)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (hyperlipideamia)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin D)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Alterations in comorbidities (sleeping apnea)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (protein)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin A)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B6)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B1)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Late minor complications(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin B12)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (vitamin E)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Development of malnutrition (calcium)(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))
  • Late major complications(January 2021 (2 yr follow-up), january 2024 (5 yr follow-up), january 2029 (10 yr follow-up))

研究者

发起方
Värmland County Council, Sweden
申办方类型
Other Gov
责任方
Sponsor

相似试验

已完成
3 期
Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host DiseaseGraft vs Host DiseaseOral Manifestations
NCT01699412Grupo de Estudos Multicentricos em Onco-Hematologia28
已完成
2 期
Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular OedemaMacular EdemaDiabetic Retinopathy
NCT01298076University of Sydney61
已完成
不适用
A Tunable-tension Transobturator Tape vs Standard Transobturator Midurethral Tape for Stress Urinary IncontinenceStress Urinary Incontinence
NCT03958695Saint Petersburg State University, Russia320
Unknown
不适用
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in SloveniaEradication TreatmentsHelicobacter Pylori Infection
NCT04359966Slovenian Society for Gastroenterology and Hepatology560
终止
不适用
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy ApproachesElevated PSAProstate Cancer
NCT03632655Weill Medical College of Cornell University38