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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mesenteric Vein Thrombosis

Intervention / Treatment
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* Drug: Warfarin
* Procedure: MVT with failure of anticoagulation therapy
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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. Exclusion Criteria: 1-Patients diagnosed to have mesenteric venous occlusion but with signs of peritonitis or confirmed radiological signs of bowel infarction on admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Diagnosis of acute MVT will be based on clinical presentation &positive CT scan.(9) .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 .(11)In addition to usual care ,intravenous heparin will be started and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. (12) followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. All patients will be critically monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then second look laparotomy will be perfomed .The mortality and all complications associated with surgery will be recorded.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MVT with anticoagulation therapy(heparin &warfarin)<br>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. | Drug: Warfarin<br>* Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) 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. patients will be critically monitored for the progress of response of therapy .<br>Procedure: MVT with failure of anticoagulation therapy<br>* patients managed conservatively with anticoagulation will be monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then second look laparotomy will be performed .The mortality and all complications associated with surgery will be recorded.<br>Drug: Heparin<br>* Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) 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. patients will be critically monitored for the progress of response of therapy .<br>|
| Experimental: MVT with failure of anticoagulation therapy(heparin &warfarin)<br>patients who underwent conservative therapy with anticoagulation (heparin &warfarin) but showed no improvement . | Drug: Warfarin<br>* Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) 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. patients will be critically monitored for the progress of response of therapy .<br>Procedure: MVT with failure of anticoagulation therapy<br>* patients managed conservatively with anticoagulation will be monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then second look laparotomy will be performed .The mortality and all complications associated with surgery will be recorded.<br>Drug: Heparin<br>* Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) 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. patients will be critically monitored for the progress of response of therapy .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticoagulation therapy (heparin &warfarin) in MVO | 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 | within 3-6 months of starting treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | number of recurrent cases post conservative therapy . | within six months of starting treatment. | 
| Mortality rate | number of deaths as a complication of conservative therapy or surgery | within one year of starting treatment. |