Идёт набор NCT07464600

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

Без фазы С лечением Colorectal Surgery Enhanced Recovery CRP Point-of-care Testing Trajectory Post-operative Complication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: blood sample, Blood taken from a fingertip, Abdomino-pelvic CT scan.
Кому может быть актуально: Состояния в реестре: Colorectal Surgery, Enhanced Recovery, CRP Point-of-care Testing Trajectory, Post-operative Complication. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?

Обзор

In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.

Вмешательства

Биопрепарат blood sample
Blood CRP levels will be measured by standard blood sampling as in usual clinical practice, at D2 and D3.
Биопрепарат Blood taken from a fingertip
CRP POCT levels will be measured (from a drop of blood taken from a fingertip using a finger pricker) once the morning of surgery, the twice a day (morning and evening) after surgery of up to 5 days post-operatively, or until discharge if earlier.
Другое Abdomino-pelvic CT scan
An abdomino-pelvic CT scan with rectal opacification will be proposed if blood CRP is \>150mg/l at D2 (2nd postoperative day) or if there is an increase of more than 50 mg/l in blood CRP between two consecutive samples.

Первичные конечные точки

occurrence of an anastomotic fistula [Срок оценки: within 90 days]

Вторичные конечные точки (10)

predictive character of AL of the trajectory of CRP POCT [Срок оценки: within 90 days]
Effective rate of antibiotic prescription [Срок оценки: 2 years]
pain quantification [Срок оценки: 2 years]
Morbi-mortality rate [Срок оценки: 2 years]
Length of hospital stay [Срок оценки: 2 years]
Unscheduled consultation rate [Срок оценки: 2 years]
Unscheduled rehospitalization rate [Срок оценки: 2 years]
Unscheduled reoperation rate [Срок оценки: 2 years]
AL mortality [Срок оценки: 2 years]
AL related secondary stoma rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.