Single-port Versus Multi-port Robotic Surgery for Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-port robotic total mesorectal excision, Multi-port robotic total mesorectal excision.
- Who it may be relevant to
- Registry conditions: Rectal Cancer Patients, Robotic Surgical Procedures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2 Non-randomized Controlled Study Based on the IDEAL Framework
Overview
Single-port versus multi-port robotic surgery for rectal cancer
Detailed description
This study is a stage 2 clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.
This study was conducted in two phases:
Phase I (Stage 2a): A single-arm study of single-port robotic radical resection for rectal cancer (n=20) Phase II (Stage 2b): A prospective non-randomized controlled study comparing single-port (n=100) versus multi-port (n=100) robotic radical resection for rectal cancer
Interventions
- Procedure Single-port robotic total mesorectal excision
Single-port robotic total mesorectal excision - Procedure Multi-port robotic total mesorectal excision
Multi-port robotic total mesorectal excision
Primary outcome measures
- Incidence of perioperative complications [Time frame: Intraoperative and postoperative 30 days]
- Number of participants with conversion procedures [Time frame: Date of surgery (Day 1)]
Secondary outcome measures (3)
- Pain scores [Time frame: Postoperative days 1-3]
- Quality of specimen [Time frame: Date of surgery (Day 1)]
- Total length of incisions [Time frame: Date of surgery (Day 1)]
Eligibility criteria
Inclusion criteria comprised: (1) MRI-confirmed distal tumor margin <15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huichao Zheng — Chongqing
Identifiers
NCT: NCT06824688 · SPORTS-02