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临床试验/NCT06442215
NCT06442215招募中不适用

Selection of Surgical Technique in Rectal Cancer Through the Development of a Predictive Model for Optimal Oncological Outcomes

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta1 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2024年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
333
试验地点
1
主要终点
Suboptimal oncological outcomes

研究概览

简要总结

Currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. The application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes.

Therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision.
  • Age ≥ 18 years.
  • Histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy.
  • Initial stage T1-T4a. Any N. Any M.
  • Intention for R0 resection.

排除标准

  • Colorectal tumor with histology different from adenocarcinoma.
  • Synchronous colon tumor.
  • Benign pathology or adenoma.
  • T4b or oncological multivisceral resections.
  • History of neoplastic colorectal surgery or local excision or TAMIS.
  • Perforated or obstructive rectal neoplasm.

结局指标

主要结局

Suboptimal oncological outcomes

时间窗: 15 postoperative days

Surgical resection with affected margins (proximal-distal and/or circumferential \< 1mm) and/or incomplete or nearly complete mesorectal resection

次要结局

  • Overall and disease free survival(3-years surgery)
  • Surgical and Postoperative complications(30 postoperative days)

研究者

发起方
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
申办方类型
Other
责任方
Sponsor

研究点 (1)

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