Clinical trial NCT03483207: Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
Official title: Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mesenteric Vein Thrombosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anticoagulation therapy (heparin &warfarin) in MVO
timeFrame: within 3-6 months of starting treatment.
Secondary outcomes:
measure: Recurrence rate
timeFrame: within six months of starting treatment.
measure: Mortality rate
timeFrame: within one year of starting treatment.
Other outcomes:
Locations:
Study officials:
References:
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citation: Zhang J, Duan ZQ, Song QB, Luo YW, Xin SJ, Zhang Q. Acute mesenteric venous thrombosis: a better outcome achieved through improved imaging techniques and a changed policy of clinical management. Eur J Vasc Endovasc Surg. 2004 Sep;28(3):329-34. doi: 10.1016/j.ejvs.2004.06.001.
citation: Harnik IG, Brandt LJ. Mesenteric venous thrombosis. Vasc Med. 2010 Oct;15(5):407-18. doi: 10.1177/1358863X10379673.
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citation: Rhee RY, Gloviczki P, Mendonca CT, Petterson TM, Serry RD, Sarr MG, Johnson CM, Bower TC, Hallett JW Jr, Cherry KJ Jr. Mesenteric venous thrombosis: still a lethal disease in the 1990s. J Vasc Surg. 1994 Nov;20(5):688-97. doi: 10.1016/s0741-5214(94)70155-5.
citation: Kumar S, Kamath PS. Acute superior mesenteric venous thrombosis: one disease or two? Am J Gastroenterol. 2003 Jun;98(6):1299-304. doi: 10.1111/j.1572-0241.2003.07338.x.
citation: Pabinger I, Schneider B. Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose- und Hamostaseforschung (GTH) Study Group on Natural Inhibitors. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):742-8. doi: 10.1161/01.atv.16.6.742.
citation: Brunaud L, Antunes L, Collinet-Adler S, Marchal F, Ayav A, Bresler L, Boissel P. Acute mesenteric venous thrombosis: case for nonoperative management. J Vasc Surg. 2001 Oct;34(4):673-9. doi: 10.1067/mva.2001.117331.