RISE Ileocecal Valve Functional Reconstruction

Официальное название

RISE Ileocecal Valve Functional Reconstruction for the Prevention of Postoperative Intestinal Dysfunction After Robotic/Laparoscopic Right Hemicolectomy: a Single-blind, Two-arm, Multicenter Randomized Controlled Clinical Study

Обзор

The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.

Вмешательства

• Процедура RISE (Revolute Insert Side-End ileocecal valve reconstruction)
  After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.

Первичные конечные точки

• Time to first formed stool after surgery (Bristol stool score < 4). [Срок оценки: 1 week after surgery]

Вторичные конечные точки (12)

• Operation time [Срок оценки: during the surgery]
• anastomosis time [Срок оценки: during surgery]
• intraoperative blood loss [Срок оценки: during surgery]
• Complications within 30 days after surgery [Срок оценки: 30 days after surgery]
• anastomosis healing [Срок оценки: 3 months, 6 months and 1 year after surgery]
• albumin level [Срок оценки: 3 days, 1 month, 3 months, 6 months and 1 year after surgery.]
• bile acid [Срок оценки: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
• VitB12 [Срок оценки: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
• total protein [Срок оценки: 3 days, 1 month, 3 months, 6 months and 1 year after surgery]
• EORTCQLQ-C30 [Срок оценки: baseline, 1 month after surgery.]
• EORTCQLQ-CR2930 [Срок оценки: baseline, 1 month after surgery.]
• gut microbiota [Срок оценки: 1 month, 3 months, 6 months and 1 year after surgery.]

Критерии участия

Критерии включения

• Subjects aged 18-80 years;
• ASA score ≤ 3;
• Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure of the colon, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic radical right hemicolectomy;
• No history of other gastrointestinal diseases (except for intestinal polyps or gallstones);
• Willing to participate in the study and sign the informed consent form;
• Complete clinical data available.

Критерии исключения

• Presence of other malignant tumors in different organs;
• Tumor invasion into adjacent organs;
• Patients with concurrent infectious diseases or autoimmune diseases (e.g., Crohn's disease);
• Patients with congenital or acquired metabolic disorders;
• Use of antibiotics or other microbiota-altering medications within one month prior to enrollment;
• Changes in surgical plan resulting in the resection not including the ileocecal valve.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07167420 · RISE anastomosis 002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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