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临床试验/NCT03483207
NCT03483207Unknown不适用

Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies

Assiut University0 个研究点目标入组 30 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
主要终点
Anticoagulation therapy (heparin &warfarin) in MVO

研究概览

简要总结

Initial treatment in the management of acute mesenteric vein thrombosis (MVT) is controversial. Some authors have proposed a surgical approach, whereas others have advocated medical therapy (anticoagulation). In this study, the investigators analyzed and compared the results obtained with surgical and medical treatment to determine the best initial management for this disease.

详细描述

Mesenteric venous thrombosis (MVT) is increasingly recognized as a cause of mesenteric ischemia. it must be distinguished from arterial and non occlusive types of ischemia, it accounts for 5% to 15% of all cases of mesenteric ischemia. Patients may have evocative signs,such as abdominal pain that is out of proportion to physical signs, nausea, or vomiting. However, a clinical diagnosis is often difficult because abdominal symptoms are non specific and high index of suspicion is often required for diagnosis.(1) Primary MVT accounted for 25% to 55% of cases in early studies, but recent reports show decline in primary MVT because of improvements in the diagnosis of hypercoagulable states.(2) Advances in new imaging techniques also have enabled early recognition of this disease without or before laparotomy.(3-5 ) Fortunately , there is no consensus about the initial management of MVT; Some authors have proposed an aggressive surgical approach (6) while others have advocated an initial conservative management with anticoagulation and close monitoring . ( 7) similarly,issue of second look laparotomy,mandatory or selective is yet not resolved.

The present study is prompted to analyze our experience in an effort to resolve these controversies and the results obtained will be assessed to determine the best management strategy for this uncommon disease.

研究设计

研究类型
Interventional
分配方式
Non 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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted in the department of surgery in Assiut University diagnosed to have mesenteric venous occlusion not presented by signs of peritonitis or confirmed radiological signs of bowel infarction.

排除标准

  • 1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.

研究组 & 干预措施

MVT with anticoagulation therapy(heparin &warfarin)

Experimental

patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively with anticoagulation(heparin &warfarin) while other cases will be for surgical management and not included in the study.

干预措施: Warfarin (Drug)

MVT with anticoagulation therapy(heparin &warfarin)

Experimental

patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively with anticoagulation(heparin &warfarin) while other cases will be for surgical management and not included in the study.

干预措施: MVT with failure of anticoagulation therapy (Procedure)

MVT with anticoagulation therapy(heparin &warfarin)

Experimental

patients with confirmed diagnosis of acute MVT on CT scan but having no signs of peritonitis or established CT signs of gangrene will be treated conservatively with anticoagulation(heparin &warfarin) while other cases will be for surgical management and not included in the study.

干预措施: Heparin (Drug)

MVT with failure of anticoagulation therapy(heparin &warfarin)

Experimental

patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .

干预措施: Warfarin (Drug)

MVT with failure of anticoagulation therapy(heparin &warfarin)

Experimental

patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .

干预措施: MVT with failure of anticoagulation therapy (Procedure)

MVT with failure of anticoagulation therapy(heparin &warfarin)

Experimental

patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement .

干预措施: Heparin (Drug)

结局指标

主要结局

Anticoagulation therapy (heparin &warfarin) in MVO

时间窗: within 3-6 months of starting treatment.

patients with confirmed diagnosis of acute MVT on CT scan will be treated conservatively In addition to usual care such as fluid and electrolyte balance, antibiotic coverage and nasogastric intubation ,intravenous heparin will be started and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. All patients will be critically followed up(Clinically.. Radiologically ) for the progress of response of therapy , failure to improve or worsening in condition( appearance of signs of peritonitis such as guarding, rigidity and fever...or radiological signs of bowel infarction) will be assessed . Factors that may affect the response such as ( age, duration from onset of the disease till starting therapy,underlying diseases,.. )also complications (hemorrhage, failure ,..)will be assessed

次要结局

  • Recurrence rate(within six months of starting treatment.)
  • Mortality rate(within one year of starting treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Hamada

Resident at General surgery department

Assiut University

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