NCT07522294

Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jeng-Fu You · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rectal Neoplasms
• Rectal Cancer Patients
• Rectal Benign Lesions

Interventions

Type	Name	Description
DEVICE	da Vinci SP Surgical System	This intervention involves the use of a single-port robotic platform to perform transanal excision of rectal tumors. The procedure includes robotic docking, precise tumor dissection with wristed instrumentation, and robotic-assisted closure of the rectal defect.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-17

Locations

1 site across 1 country: Taiwan