Glycocalyx Monitoring in Major Abdominal Surgery

NCT ID: NCT06285526

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-05

Study Completion Date

2025-01-05

Brief Summary

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The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.

Detailed Description

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This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.

Conditions

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Major Abdominal Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group HIPEC

Cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Intervention Type PROCEDURE

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Group CDP

Cephalic DuodenoPancreatectomy (CDP)

Cephalic DuodenoPancreatectomy

Intervention Type PROCEDURE

Cephalic DuodenoPancreatectomy

Interventions

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Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Intervention Type PROCEDURE

Cephalic DuodenoPancreatectomy

Cephalic DuodenoPancreatectomy

Intervention Type PROCEDURE

Other Intervention Names

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HIPEC CDP

Eligibility Criteria

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Inclusion Criteria

For the HIPEC group :

* Adult patients
* Age \< 75 years
* Receiving HIPEC for primary or secondary peritoneal carcinosis

For the CDP group :

* Adult patient
* Age \< 75 years
* Receiving CDP for pancreatic neoplasia
* Patient who has read and understood the information letter and does not object to taking part in the study
* Patient affiliated to a social security scheme

Exclusion Criteria

* Secondary distant peritoneal metastases
* Chronic heart failure
* Chronic liver failure at stage C of the Child-Pugh score
* Stage IV or V chronic renal failure
* Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
* Patient refusal
* Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zoé DEMAILLY, Dr

Role: PRINCIPAL_INVESTIGATOR

University Rouen Hospital

Locations

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Rouen University Hospital

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Zoé DEMAILLY, Dr

Role: CONTACT

02 32 88 24 40 ext. +33

Emmanuel BESNIER, Pr

Role: CONTACT

02 32 88 82 92 ext. +33

Facility Contacts

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DEMAILLY Zoé, MD

Role: primary

02 32 88 24 40 ext. +33

Thomas CLAVIER, MD

Role: backup

02 32 88 82 92 ext. +33

Other Identifiers

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2023-A00350-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023/0046/OB

Identifier Type: -

Identifier Source: org_study_id

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