Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Procedure-Related Adverse Events
研究概览
简要总结
Title Case Summary: "This study evaluates the safety, feasibility, and short-term clinical outcomes of a new surgical approach called Single-Port (SP) Robotic Transanal Minimally Invasive Surgery (SPR TAMIS) for treating rectal tumors."
Content:
Transanal Minimally Invasive Surgery (TAMIS) is a standard technique for treating early-stage rectal tumors. However, traditional TAMIS often faces challenges such as restricted vision and instrument crowding in the narrow rectum.
The purpose of this study is to establish a standardized surgical procedure using a single-port robotic platform, which provides better flexibility and visualization. The investigators will analyze real-world clinical cases and surgical videos to assess key outcomes, including the success of tumor resection (R0 resection rate), operative safety, and patient recovery parameters. The study aims to provide clinical evidence for this robotic technique and facilitate its standardized implementation in surgical practice.
详细描述
Transanal Minimally Invasive Surgery (TAMIS) is a key minimally invasive technique for the treatment of early-stage rectal tumors and selected rectal lesions. It offers advantages such as organ preservation, avoidance of abdominal incisions, reduced complications, and accelerated postoperative recovery. However, conventional TAMIS procedures are often limited by instrument crowding and restricted operative vision, especially within the narrow confines of the rectum.
The single-port robotic platform provides enhanced flexibility, articulation, and visualization, offering a promising solution to the technical challenges of transanal surgery. This study aims to establish a standardized surgical protocol for SP-assisted Robotic TAMIS (SPR TAMIS) and to evaluate its clinical safety, feasibility, and short-term outcomes.
The investigators will incorporate real-world clinical cases and intraoperative videos to perform procedural decomposition, analyze key surgical steps, assess R0 resection rates, and measure recovery-related parameters. In parallel, the project will develop a dedicated educational module and performance evaluation tools to support skill transfer and broader clinical implementation.
This project is expected to facilitate the standardization of the Robotic TAMIS workflow, provide evidence for its clinical efficacy, and build a structured training platform. This project will help establish a standardized framework for robotic transanal surgery, improve patient care through precise and less invasive techniques, and foster broader clinical integration of advanced robotic platforms within Taiwan's surgical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with benign rectal lesions, including large adenomas or polyps not amenable to standard endoscopic removal
- •Patients with recurrent or residual rectal lesions following incomplete endoscopic resection
- •Patients with early-stage rectal cancer (clinical T1 tumors confined to the submucosa) with favorable histologic features (e.g., well-differentiated, no lymphovascular or perineural invasion)
- •Select patients with T2 rectal cancer who are medically unfit for radical surgery or require local palliation
- •Patients with clinically downstaged rectal cancer (e.g., cT0 or near-complete response) following neoadjuvant chemoradiotherapy, in whom TAMIS may be used for local excision to confirm pathological response
排除标准
- •Patients undergoing excision of rectal neuroendocrine tumors
- •Patients with bulky tumors or advanced disease (clinical T3-T4)
- •Patients with radiologic or clinical evidence of nodal involvement
- •Patients with high-risk histologic features (e.g., lymphovascular invasion, perineural invasion, poor differentiation), unless TAMIS is performed for palliative purposes or in patients unfit for radical surgery
- •Patients in whom completion radical surgery is clearly indicated based on preoperative assessment
研究组 & 干预措施
SPR TAMIS Group
Participants with early-stage rectal tumors or lesions undergoing Transanal Minimally Invasive Surgery (TAMIS) using a single-port robotic platform.
干预措施: da Vinci SP Surgical System (Device)
结局指标
主要结局
Number of Participants With Procedure-Related Adverse Events
时间窗: Within 30 days postoperatively
Number of participants experiencing procedure-related adverse events within 30 days after surgery, graded according to the Clavien-Dindo classification.
次要结局
- Number of Standardized Surgical Steps Identified(Throughout the study period (Expected 1 year))
研究者
Jeng-Fu You
Chief, Division of Colorectal Surgery and Professor
Chang Gung Memorial Hospital