A Prospective, Randomized, Parallel-Controlled, Superiority Clinical Study Comparing Transanal Total Mesorectal Excision (taTME) and Robot-Assisted Total Mesorectal Excision (RTME) in the Treatment of Low Rectal Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
TME remains standard treatment for rectal cancer. Both Robotic TME and taTME are innovative surgical techniques with potential advantages in low rectal cancer. To date, no clinical studies have directly compared the conversion and complication rates between taTME and RTME in this population. Therefore, the investigators propose to conduct a prospective, randomized, parallel-controlled clinical trial comparing taTME with RTME for low rectal cancer, aiming to provide high-level evidence for surgical decision-making and benefit more patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• ECOG performance status 0-1. Informed consent obtained.
Locations
Other Locations
China
the sixth affiliated hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Liang Kang, MD
kangl@mail.sysu.edu.cn
+8613602886833
Backup
Ling Shuang Luo, MD
kangl@mail.sysu.edu.cn
+8613751756175
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2029-04-28
Participants
Target number of participants: 216
Treatments
Active_comparator: robotic TME
For patients with low rectal cancer, the da Vinci multi-arm robotic system is used to perform total mesorectal excision (TME). The procedure includes vascular ligation, mesenteric mobilization, distal bowel transection beyond the tumor, and anastomosis, all completed transabdominally with robotic assistance.
Experimental: taTME
For patients with low rectal cancer, a combined transanal and transabdominal approach is used to complete the total mesorectal excision (TME). A purse-string suture is placed approximately 1 cm below the distal tumor margin, followed by insertion of a single-port device. The mesorectum is then mobilized from bottom to top. Vascular ligation is performed laparoscopically via the abdominal approach. The two teams (transanal and transabdominal) meet near the peritoneal reflection.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University