Comparing single-port and multi-port robotic surgery for rectal cancer
Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2a Non-randomized Controlled Study Based on the IDEAL Framework
This study is testing whether single-port robotic surgery is safer and helps patients recover faster than multi-port robotic surgery for people with rectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT06824688 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and short-term clinical efficacy of single-port robotic total mesorectal excision compared to multi-port robotic total mesorectal excision in patients with rectal cancer. It follows the IDEAL framework and focuses on various clinical outcomes, including intraoperative complications, blood loss, and postoperative recovery metrics. The study aims to determine which surgical approach offers better results in terms of complications and recovery time for patients undergoing surgery for rectal cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage I-III rectal adenocarcinoma who are eligible for anal sphincter-preserving surgery.
Not a fit: Patients with previous rectal resections, acute intestinal obstruction, or certain hereditary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for rectal cancer patients.
How similar studies have performed: Other studies have explored robotic surgery techniques, but this specific comparison of single-port versus multi-port approaches is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Chongqing
- Huichao Zheng — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Huichao Zheng, MD
- Email: 625730455@qq.com
- Phone: 68757350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.