Clinical trial · Interventional
Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Benign Lesions | — | UNRESOLVED | — |
| Rectal Cancer Patients | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| da Vinci SP Surgical System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPR TAMIS Group
- description
- Participants with early-stage rectal tumors or lesions undergoing Transanal Minimally Invasive Surgery (TAMIS) using a single-port robotic platform.
- interventionNames
- Device: da Vinci SP Surgical System
Primary outcomes (1)
- measure
- Number of Participants With Procedure-Related Adverse Events
- timeFrame
- Within 30 days postoperatively
- description
- Number of participants experiencing procedure-related adverse events within 30 days after surgery, graded according to the Clavien-Dindo classification.
Secondary outcomes (1)
- measure
- Number of Standardized Surgical Steps Identified
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available