Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
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: MTI-TME, C-TME.
- Кому может быть актуально
- Состояния в реестре: Rectal Cancer. Базовые параметры: 18 лет — 75 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
- Список центров уточняется — проверьте первичный протокол.
- 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
A Randomized Controlled Study of Multi-technology Integration Total Mesorectal Excision (MTI-TME) Versus Conventional Total Mesorectal Excision (C-TME) for the Treatment of Middle and Distal Rectal Cancer.
Обзор
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
Подробное описание
Currently, laparoscopic total mesorectal excision (TME) has become the standard procedure for treating middle and distal rectal cancer. Anastomotic leakage has always been one of the serious complications of TME surgery, and Anastomotic leakage not only increases the hospital expenses, but also brings physical discomfort and psychological pain to the patients. Furthermore, anastomotic leakage is associated with a heightened risk of anastomotic stenosis, compromised bowel function, delayed initiation of postoperative adjuvant therapy, increased local recurrence rates post-surgery, and diminished long-term survival outcomes. A report from the Netherlands indicates that anastomotic leakage serves as an independent prognostic factor for overall survival in patients diagnosed with rectal cancer. Prior studies have documented the incidence of anastomotic leakage to range between 3.6% and 21%, attributable to a confluence of various factors including technical complications, oncological considerations, and the patient\'s overall health status. Among these determinants, aspects such as blood supply adequacy, tension at the site of anastomosis, tissue quality, and anatomical positioning of the rectum are widely recognized as significant risk factors for developing anastomotic leaks.Currently, several strategies are employed to mitigate the incidence of anastomotic leakage, including preoperative proctocolectomy, anal decompression placement, vertical transverse resection of the rectum, and anastomotic reinforcement techniques. In our clinical practice, we have innovatively integrated multiple approaches: (1) preservation of the left colic artery (LCA); (2) high-level resection of the inferior mesenteric vein (IMV); (3) standardized mobilization of the splenic flexure along with left lateral colon; (4) multi-plane dissection of mesorectal flaps; and (5) selective reinforcement at the anastomosis. Our findings indicate that multi-technology integrated total mesorectal excision (MTI-TME) significantly reduces both preventive stoma rates and incidences of anastomotic leakage compared to conventional total mesorectal excision (C-TME), . However, there remains a lack of robust evidence-based medicine supporting MTI-TME\'s advantages in treating middle and distal rectal cancer; further research is urgently needed to provide additional clinical evidence.
Вмешательства
- Процедура MTI-TME
Multi-Technology Tntegrated Total Mesorectal Excision,MTI-TME - Процедура C-TME
Conventional Total Mesorectal Excision,C-TME
Первичные конечные точки
- anastomotic leakage rate [Срок оценки: 1 year]
Вторичные конечные точки (12)
- Operation time [Срок оценки: During surgery]
- intraoperative blood loss [Срок оценки: During surgery]
- 3-year overall suvival rate [Срок оценки: 3 years]
- local recurrance rate [Срок оценки: 3 years]
- 3-year disease-free survival rate [Срок оценки: 3 years]
- 3-year mortality rate [Срок оценки: 3 years]
- postoperative quality of life [Срок оценки: 3 years]
- intestinal exhaust time [Срок оценки: 1 year]
- postoperative pain [Срок оценки: 1 year]
- colostomy rate [Срок оценки: 1 year]
- hospital stay [Срок оценки: 1 year]
- hospital cost [Срок оценки: 1 year]
Критерии участия
Критерии включения
- Participants must be aged 18 to 75.
- Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
- Preoperative MRI shows the tumor\'s lower margin is below the umbilical ligament.
- High-resolution CT and MRI do not indicate suspicious distant metastasis.
- Participants\' general condition is acceptable, with an ASA score of ≤3 before surgery.
- Participants must sign an informed consent form.
Критерии исключения
- Developing other malignant tumors within 5 years;
- Multiple primary colorectal tumors;
- Pregnant or lactating women;
- Patients with severe mental disorders;
- Severe intestinal diseases;
- Poor general condition and uncontrolled comorbidities;
- Ineligible for laparoscopic surgery;
- Participating in other clinical trials.
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06613399 · PRSYM202409