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

NCT07522294 | Active Not Recruiting

• 1 other identifier: 202501208A3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer Patients; Rectal Benign Lesions; Rectal Neoplasms

Keywords

TAMIS (Transanal Minimally Invasive Surgery); Robotic Surgery; Single-port Robot; SPR TAMIS; Transanal Surgery; Minimally Invasive Surgery; Natural Orifice Transluminal Endoscopic Surgery (NOTES)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Procedure-Related Adverse Events

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

  Within 30 days postoperatively

Secondary Outcomes (1)

• Number of Standardized Surgical Steps Identified

  Throughout the study period (Expected 1 year)

Other Outcomes (1)

• Surgical Competency in SPR TAMIS

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

Study Arms (1)

SPR TAMIS Group

EXPERIMENTAL

Participants with early-stage rectal tumors or lesions undergoing Transanal Minimally Invasive Surgery (TAMIS) using a single-port robotic platform.

Device: da Vinci SP Surgical System

Interventions

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.

SPR TAMIS Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeng-Fu You: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• JENG-FU YOU

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Colorectal Surgery and Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: April 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)