The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery

The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are: 1. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer? 2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery. Participants will: 1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio. 2. Receive the corresponding surgical intervention. 3. Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery. 4. Provide relevant clinical data (perioperative, pathological, follow-up) as required.

NCT Number	NCT07369531
Lead Sponsor	The First Hospital of Jilin University Collaborators: The First Affiliated Hospital of Zhengzhou University, Sixth Affiliated Hospital, Sun Yat-sen University
Conditions	Rectal Cancer, Surgical Anastomosis, Survival , Tumor, Anal Function, Stoma
Enrollment	520 participants
Start Date	2026-03-18
Primary Completion	2031-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-25