Cohort SURVI : Intestinal Ischemia and Vascular Diseases (Survibase)

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.

Study Overview

• Status: Recruiting
• Conditions: Mesenteric Ischemia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Olivier CORCOS; Phone Number: 0140875000; Email: olivier.corcos@aphp.fr

Study Locations

• France
  • Clichy, France, 92110
    • Recruiting
    • Olivier CORCOS
    • Contact: Olivier CORCOS; Phone Number: 0140875000; Email: olivier.corcos@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

active patient file of the SURVI service

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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	5 years
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors	1 year
To study the risk of vascular restenosis in all revascularised patients with IIVD and its associated factors	5 years
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.	1 year
To study the incidence of recurrence or ischaemic complications (acute or chronic) in IIVD and their associated factors.	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Anticipated): January 4, 2041
• Study Completion (Anticipated): January 4, 2041

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Vascular Diseases; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: APHP200184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No