Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

Официальное название

Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

Обзор

To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。

Вмешательства

• Процедура laparoscopic colorectal day surgery
  laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
• Процедура traditional laparoscopic colorectal surgery
  traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

Первичные конечные точки

• Recurrence-free survival (DFS) [Срок оценки: From enrollment to the end of treatment at 36 months]
• Overall survival (OS) [Срок оценки: From enrollment to the end of treatment at 36 months]

Вторичные конечные точки (7)

• BIood system disorders [Срок оценки: From enrollment to the end of treatment at 1 week]
• Pain evaluation [Срок оценки: From one hour after surgery to the end of treatment at 48 hours]
• Cardiac disorders [Срок оценки: From enrollment to the end of treatment at 1 week]
• CoIonic fistuIa [Срок оценки: From enrollment to the end of treatment at 1 week]
• AbdominaI infection [Срок оценки: From enrollment to the end of treatment at 1 week]
• AnorectaI infection [Срок оценки: From enrollment to the end of treatment at 1 week]
• Fever [Срок оценки: From enrollment to the end of treatment at 1 week]

Критерии участия

Критерии включения

• Patients voluntarily joined this study and signed an informed consent form；
• Age: 18-75 years old；
• The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I\~III)；
• Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
• Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
• Preoperative staging: cT1-3NanyM0;
• Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
• There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
• Does not require conventional anticoagulant therapy or antiplatelet therapy；
• Relatives or co-residents should be able to provide 24 hours of full escort within at least 72 hours after the operation, the place of residence is not more than a 30-minute drive from the hospital, and they can understand and follow the phased treatment plan of diet, analgesic drugs, etc. after the operation.

Критерии исключения

• Elderly patients with multiple basic diseases；
• Moderate to severe anemia；
• Severe hypoproteinemia；
• Diabetes that is not well controlled；
• Contraindications to laparoscopic surgery；
• Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
• Patients with distant metastases；
• Patients who are unwilling to sign informed consent or follow-up according to the research plan；
• People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
• Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
• After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
• According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the patient\'s research.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT06637215 · FirstHCMU_ambulatory_surgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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