Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial

Официальное название

A Single - Center, Prospective,Controlled Clinical Trial Exploring the Function of Betacyanin in the Early Diagnosis and Subsequent Recovery From Anastomotic Leakage After Rectal Cancer Surgery

Обзор

This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.

Вмешательства

• Пищевая добавка Betacyanin
  200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
• Диагностический тест Pelvic Drainage Fluid Betacyanin Assay
  Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage

Первичные конечные точки

• Time to Diagnosis of Anastomotic Leakage [Срок оценки: Within 30 days after surgery]

Вторичные конечные точки (8)

• Diagnostic Performance of Betacyanin for Anastomotic Leakage [Срок оценки: Within 30 days after surgery]
• Time to Healing of Anastomotic Leakage [Срок оценки: Within 30 days after surgery]
• Incidence of Postoperative Grade III-IV Complications [Срок оценки: Within 30 days after surgery]
• Reoperation Rate [Срок оценки: Within 30 days after surgery]
• Length of Postoperative Hospital Stay [Срок оценки: From surgery to hospital discharge, assessed up to 30 days]
• 30-Day Readmission Rate [Срок оценки: Within 30 days after hospital discharge]
• Cost of Anastomotic Leakage Diagnosis [Срок оценки: During index hospitalization, assessed up to 30 days]
• Total Hospitalization Cost [Срок оценки: During index hospitalization, assessed up to 30 days]

Критерии участия

Критерии включения

• Pathologically confirmed rectal adenocarcinoma prior to surgery.
• Undergoing laparoscopic anterior resection for rectal cancer.
• No prophylactic diverting ileostomy.
• American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 3.
• No prior history of malignant tumors, and no evidence of other malignancies on preoperative examination.
• Written informed consent obtained from the patient or a legally authorized representative.

Критерии исключения

• Prior abdominal surgery with severe intra-abdominal adhesions.
• Currently participating in, or having participated within the past 6 months in, another clinical study related to rectal cancer surgery.
• Preoperative complications requiring emergency surgery, including bleeding, perforation, or obstruction.
• History of prior malignancy.
• Undergoing Parks procedure with anastomosis at the anal verge, or Miles procedure, or Hartmann's procedure.
• Preoperative neoadjuvant chemoradiotherapy, or presence of other high-risk factors for anastomotic leakage requiring a prophylactic diverting ileostomy.
• ASA Physical Status Classification > 3.
• Patient withdrawal of consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• General Surgery Center of PLA — Чунцин

Идентификаторы

NCT: NCT07726966 · TBo20251116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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