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Набор по приглашению NCT07346534

Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study

Без фазы С лечением Low Rectal Cancer Rectal Neoplasms Colorectal 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: Reinforced Anastomotic Suturing (8-10 Interrupted Sutures), Conventional Laparoscopic Dixon Procedure.
Кому может быть актуально
Состояния в реестре: Low Rectal Cancer, Rectal Neoplasms, Colorectal Cancer. Базовые параметры: 18 лет — 85 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
Китай
Следующий шаг
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Обзор

Study Description This prospective, controlled clinical study aims to compare the clinical outcomes of reinforced anastomosis using 8-10 interrupted sutures versus the conventional Dixon procedure in patients undergoing laparoscopic low anterior resection for low rectal cancer. Anastomotic leakage remains one of the most significant postoperative complications following low rectal cancer surgery, particularly in laparoscopic procedures due to limited tactile feedback and maneuverability in the pelvic cavity. Reinforcement of the anastomotic site through additional interrupted suturing may provide better mechanical strength and improved healing, potentially reducing the incidence of anastomotic leakage and related morbidities. In this study, eligible patients will be assigned to receive either a conventional laparoscopic Dixon procedure or the same procedure with added reinforcement of the anastomosis using 8-10 interrupted sutures circumferentially. Perioperative outcomes including the rate of anastomotic leakage, postoperative complications, operation time, length of hospital stay, return of bowel function, and quality of life will be assessed and compared between the two groups. The study seeks to provide evidence for optimizing surgical techniques in low rectal cancer treatment and improving patient prognosis.

Вмешательства

  • Процедура Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)
    After completing the laparoscopic low anterior resection (Dixon procedure) for low rectal cancer, the surgeon performs additional reinforcement of the colorectal anastomosis. This is done by placing 8 to 10 interrupted seromuscular sutures circumferentially around the anastomotic site. The goal of this reinforcement is to enhance anastomotic stability, promote healing, and reduce the risk of anastomotic leakage.
  • Процедура Conventional Laparoscopic Dixon Procedure
    Patients undergo standard laparoscopic low anterior resection (Dixon procedure) for low rectal cancer. The colorectal anastomosis is performed using a circular stapler without any additional suturing or reinforcement. This represents the conventional surgical approach widely used in clinical practice.

Первичные конечные точки

  • Incidence of Anastomotic Leakage [Срок оценки: Within 30 days postoperatively]
Вторичные конечные точки (3)
  • Postoperative Complication Rate [Срок оценки: Up to 30 days after surgery]
  • Operation Time [Срок оценки: During the surgical procedure]
  • Length of Postoperative Hospital Stay [Срок оценки: From date of surgery through date of discharge, up to 30 days]

Критерии участия

Критерии включения

  • Age between 18 and 85 years.
  • Diagnosed with low rectal adenocarcinoma located within 7 cm from the anal verge by colonoscopy and biopsy.
  • Scheduled for elective laparoscopic low anterior resection (Dixon procedure).
  • Clinical stage I-III (based on preoperative imaging, e.g., MRI/CT) without distant metastasis.
  • Adequate organ function (hematologic, hepatic, renal) to tolerate surgery.
  • Provided written informed consent and willing to comply with study procedures and follow-up.

Критерии исключения

  • Presence of synchronous distant metastases or other malignancies.
  • History of prior pelvic radiotherapy or major pelvic surgery.
  • Severe uncontrolled comorbidities (e.g., severe cardiovascular, respiratory, hepatic or renal insufficiency).
  • Emergency surgery indication (e.g., bowel obstruction, perforation).
  • Pregnancy or breastfeeding.
  • Known allergy or contraindication to anesthesia or surgical materials used.
  • Participation in another interventional clinical trial within the last 3 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 1 центр
  • Shanghai Tenth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07346534 · 25K50

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗