Actively Recruiting
The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery
Led by The First Hospital of Jilin University · Updated on 2026-03-25
520
Participants Needed
2
Research Sites
302 weeks
Total Duration
On this page
Sponsors
T
The First Hospital of Jilin University
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years with rectal adenocarcinoma confirmed by biopsy
- No distant metastasis on preoperative abdominal and lung CT or PET-CT
- Tumor located within 5 cm below the anal margin, above the internal-external anal sphincter groove by 1 cm, without external anal sphincter invasion
- Tumors above levator ani hiatus staged cT1-3, cN0-1, M0, MRF negative; tumors below levator ani hiatus staged cT1-2, cN0-1, M0, MRF negative; downstaged tumors after neoadjuvant therapy as specified
- Preoperative body mass index under 28 kg/m²
- Patients underwent radical laparoscopic, robot-assisted, or transanal total mesorectal excision surgery
You will not qualify if you...
- Having other primary malignant tumors or multiple distant colorectal cancers
- History of open (non-minimally invasive) surgery
- Failure to complete preoperative rectal MRI and chest/abdominal imaging for tumor staging
- Pregnant or having inflammatory bowel disease
- Complete intestinal obstruction before surgery or requiring emergency surgery
- Need for multivisceral or combined organ resection before or during surgery
- Recent treatment for other malignancies
- Low rectal cancer classified as type IV by Bordeaux system
- Confirmed distant metastasis during surgery
- Pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma
- Withdrawal criteria include refusal of surgery after randomization, undergoing abdominoperineal resection after randomization, or voluntary withdrawal at any time
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Trial Site Locations
Total: 2 locations
1
First Hospital of Jilin University
Changchun, Jilin, China, 130012
Actively Recruiting
2
First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
Q
Quan Wang Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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