Идёт набор NCT07144683

Anastomotic Leakage After Colorectal Surgery.

— Наблюдательное Anastomotic Leak Colorectal Cancer Diverticulitis

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: Patients Undergoing Colorectal Resection with Anastomosis.
Кому может быть актуально: Состояния в реестре: Anastomotic Leak, Colorectal Cancer, Diverticulitis. Базовые параметры: 18 лет — 80 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Risk Factors for Anastomotic Leakage After Colorectal Surgery.

Обзор

Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.

Подробное описание

Anastomotic leakage (AL) remains a major complication after colorectal surgery, contributing to morbidity, mortality, prolonged hospital stays, and increased costs. Its etiology is multifactorial, involving patient, disease, and surgical factors. This study will prospectively evaluate risk factors in a single-center setting to minimize variability.

AL definition (per ISGRC): Defect at anastomotic site causing communication between intra/extraluminal compartments and luminal tract, diagnosed via clinical signs (e.g., peritonitis, fecal discharge), radiological evidence (e.g., CT showing extraluminal air/contrast or fluid collection), or operative verification.

Severity grading:

* Grade A: Asymptomatic/mild, no active treatment. * Grade B: Requires intervention (e.g., drainage, antibiotics) but no reoperation. * Grade C: Requires reoperation.

Risk factors categorized as:

* Preoperative: Demographics (age, sex, BMI), comorbidities (ASA score, diabetes....), lifestyle (smoking, alcohol), nutritional status (albumin, CRP), neoadjuvant therapy, medications, diagnosis (e.g., cancer, tumor location), and bowel preparation. * Intraoperative: Approach (open/laparoscopic), resection type, anastomosis details (hand-sewn/stapled, level, perfusion assessment), peritoneal soiling, diverting stoma, operative time, blood loss/transfusion, drainage, surgeon experience, complications. * Postoperative: AL diagnosis/severity/management, inflammatory response (CRP, WBC), anemia, complications (ileus, infection), hospital stay, nutritional support, mobilization, reoperation, ICU stay, mortality, pain management.Early detection of leak using inflammatory markers either in the serum or drain fluid. Drain fluid inflammatory markers (Drain Fluid Calprotectin(CP), Drain Fluid C-Reactive Protein (CRP), Drain Fluid Procalcitonin)and Serum inflammatory markers(Serum C-Reactive Protein (CRP), Serum Procalcitonin (PCT), Serum Lactate dehydrogenase (LDH)).

Data from electronic records, surgical notes, nursing charts, and follow-up. Statistical analysis includes descriptive stats, univariate/multivariate logistic regression for risk factors, subgroup analyses, and predictive model development/validation.

The study adheres to the Helsinki Declaration and Good Clinical Practice (GCP). Informed consent is required.

Вмешательства

Процедура Patients Undergoing Colorectal Resection with Anastomosis
All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)

Первичные конечные точки

Incidence of Anastomotic Leakage (AL) [Срок оценки: Within 30 days post-surgery.]

Вторичные конечные точки (6)

Severity of Anastomotic Leakage [Срок оценки: Within 30 days post-surgery]
Reoperation Rate Due to AL [Срок оценки: Within 30 days post-surgery]
Readmission Rate Due to AL [Срок оценки: Within 30 days post-surgery]
Length of Hospital Stay [Срок оценки: Within 30 days post-surgery.]
Mortality Rate [Срок оценки: Within 30 days post-surgery.]
Need for Permanent Stoma [Срок оценки: Within 90 days post-surgery]

Критерии участия

Критерии включения

Aged ≥18 years
Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
Providing written informed consent