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NCT Number: NCT07522294

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Da Vinci SP Surgical System

Device

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.

Primary outcomes

  1. Number of Participants With Procedure-Related Adverse Events

    Time frame: Within 30 days postoperatively

    Number of participants experiencing procedure-related adverse events within 30 days after surgery, graded according to the Clavien-Dindo classification.

Secondary outcomes

  1. Number of Standardized Surgical Steps Identified

    Time frame: Throughout the study period (Expected 1 year)

    Number of discrete procedural steps defined for SPR TAMIS based on intraoperative video analysis.

Other outcomes

  1. Surgical Competency in SPR TAMIS

    Time frame: Upon completion of the training workshops (Expected within 1-2 years)

    Surgical competency will be evaluated using a structured, procedure-specific assessment framework during SPR TAMIS procedures performed in the training workshops. The evaluation will focus on key technical domains, including instrument control, dissection precision, maintenance of operative field exposure, procedural efficiency, and quality of defect closure.

    Assessments will be conducted by expert evaluators based on direct observation or recorded procedures.

    Improvement in competency over the training period will be used to reflect skill acquisition and technical proficiency.

Sponsors and collaborators

Lead sponsor

Jeng-Fu You

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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