Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer

Официальное название

A Multicenter, Prospective, Randomized Controlled Clinical Trial of the Effect of Conformal Sphincter-preservation Operation Versus Intersphincteric Resection on Postoperative Anal Function in Patients With Low Rectal Cancer

Обзор

In this clinical trial, the investigators compared anal function, genitourinary function, quality of life, perioperative safety, and oncological prognosis after CSPO for patients with low rectal cancer, using ISR as a control, to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical approaches for patients with low rectal cancer.

Подробное описание

The CSPO surgical approach is a series of targeted improvements designed primarily on the basis of analyzing the causes of poor postoperative function of the ISR, while building on research on the ultrastructure of the pelvic floor anal canal. For these reasons, the investigators designed the present study to compare anal function, quality of life, perioperative safety, and oncologic prognosis after CSPO for patients with low rectal cancer, using ISR surgery as a control, and to provide high-level evidence-based medical evidence for the choice of anorectal preservation surgical modalities for patients with low rectal cancer.

Вмешательства

• Процедура CSPO
  The distal rectum is freed to the entrance of the internal and external sphincter space, and then an oblique resection line is designed under direct vision according to the tumor site and shape, ensuring that the distal and lateral margins are not less than 1 cm, and preserving the contralateral dentate line and the intestinal wall as much as possible, and the anastomosis is completed manually or with instruments.
• Процедура ISR
  Partial, subtotal, or total excision of the internal sphincter and/or a portion of the longitudinal rectal muscle, expansion of the distal rectal excision margin into the anal canal or to the anal verge, and completion of the colo-anal anastomosis manually or instrumentally.

Первичные конечные точки

• Wexner incontinence score [Срок оценки: 12 months after protective stoma closure]

Вторичные конечные точки (4)

• LARS scoreIncontinence Score [Срок оценки: 12 months after protective stoma closure]
• Quality of Life Questionaire-Core 30 [Срок оценки: 12 months after radical resection of rectal cancer and protective stoma closure]
• Overall survival [Срок оценки: 3 years]
• Clavien-Dindo complication grading [Срок оценки: perioperative period]

Критерии участия

Критерии включения

• Age: 18-75 years;
• Pathologically confirmed: moderately \& well-differentiated rectal cancer;
• Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
• Tumor diameter: ≤3cm or <1/3 bowel circumference;
• Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
• Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
• ASA score: I-III and ECOG score: 0-1;
• Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
• Normal preoperative anal function: Wexner score <10, LARS score <20;
• Agree to participate in the clinical trial and sign an informed consent form.

Критерии исключения

• Combination of synchronous or metachronous (within 5 years) malignant tumors;
• Combined distant metastasis of the tumor;
• Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
• Combined psychiatric disorders that do not allow them to understand and participate in the study;
• Combined systemic diseases that cannot tolerate surgery;
• Women who are pregnant or breastfeeding;
• Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.

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: NCT06567756 · CSVIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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