NCT07522294Active, not recruiting
Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Jeng-Fu You
- Diseases
- Colorectal cancer
- NCT number
- NCT07522294
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Jan 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with bulky tumors or advanced disease (clinical T3-T4)
Other
- Patients undergoing excision of rectal neuroendocrine tumors
- Patients with radiologic or clinical evidence of nodal involvement
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.