Cohort SURVI : Intestinal Ischemia and Vascular Diseases

NCT04746534 | Recruiting

• 1 other identifier: APHP200184
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%. Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors. Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient. The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described. The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

Conditions

Mesenteric Ischemia

Outcome Measures

Primary Outcomes (4)

• mortality of Intestinal Ischemia

  To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 1 year in terms of mortality.

  1 year

• mortality of Intestinal Ischemia

  To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases (IIVD) at 5 years in terms of mortality.

  5 years

• Vascular Diseases (IIVD)

  To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases

  1 year

• Vascular Diseases (IIVD)

  To study the prognosis of Intestinal (acute and chronic) Ischemia and Vascular Diseases

  5 years

Secondary Outcomes (10)

• Describe the prevalence of IIVD

  1 year

• Describe the prevalence of IIVD

  5 years

• Study mortality and its associated factors of IIVD

  1 year

• Study mortality and its associated factors of IIVD

  5 years

• Study the risk of intestinal resection of IIVD and its associated factors. Among resected patients, describe the incidence of short intestinal syndrome and dependence on parenteral nutrition

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

active patient file of the SURVI service

You may qualify if:

• Age \> 18 years old
• IMVI including :
• acute mesenteric ischaemia defined by acute digestive distress in relation to arterial and/or venous, occlusive and/or non-occlusive splanchnic-mesenteric vascular insufficiency, in the absence of an alternative diagnosis
• Chronic mesenteric ischaemia defined by chronic digestive distress (duration of symptom evolution \>30 days) related to occlusive or non- occlusive arterial or venous vascular insufficiency.
• MVI: gastrointestinal arterial or venous diseases without ischaemia (atheroma, embolism, thrombosis, dissection, mediolysis, aneurysm, dysplasia, sheathing, compression, torsion)

You may not qualify if:

• Left ischaemic colitis without damage to the celiac trunk and/or superior mesenteric artery
• Dissection of the abdominal aorta without intestinal ischaemia
• Portal thrombosis without extension to the superior mesenteric vein
• Portal thrombosis without extension to the superior mesenteric vein
• Traumatic rupture of the digestive arteries
• Non-injected abdominal scanner or no abdominal scanner
• Patient opposition to participation in research
• Patient under guardianship / curators
• Vulnerable patient: pregnant or breastfeeding women, persons deprived of their liberty, minors, adults unable or unwilling to give consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Olivier CORCOS

Clichy, 92110, France

RECRUITING

MeSH Terms

Conditions

Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peritoneal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Olivier CORCOS

CONTACT

0140875000; olivier.corcos@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: February 9, 2021
• Study Start: November 27, 2020
• Primary Completion (Estimated): January 4, 2041
• Study Completion (Estimated): January 4, 2041
• Last Updated: February 9, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)