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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
2. Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
3. Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm, and without invasion of the external anal sphincter;
4. For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below;
5. Preoperative BMI \< 28 kg/m²
6. Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).

Exclusion Criteria:

1. Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
2. History of previous open surgery (non-minimally invasive procedures);
3. Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor;
4. Pregnant patients or those with concurrent inflammatory bowel disease;
5. Preoperative patients with complete intestinal obstruction or requiring emergency surgery;
6. Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.;
7. Recent treatment for other malignancies;
8. Low rectal cancer classified as type IV in the Bordeaux classification system;
9. Intraoperatively confirmed distant metastatic disease
10. Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma.

Withdrawal Criteria

1. Patients who refuse surgical intervention after randomization.
2. Patients who undergo an abdominoperineal resection (APR) following randomization.
3. Patients who request voluntary withdrawal from the trial at any time throughout the study period.

• BACKGROUNDYamada K, Ogata S, Saiki Y, Fukunaga M, Tsuji Y, Takano M. Functional results of intersphincteric resection for low rectal cancer. Br J Surg. 2007 Oct;94(10):1272-7. doi: 10.1002/bjs.5534. PMID 17671960
• BACKGROUNDCohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont A, Shi Q, Andre T; ACCENT Group. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12. PMID 32172199
• BACKGROUNDDavid GG, Slavin JP, Willmott S, Corless DJ, Khan AU, Selvasekar CR. Loop ileostomy following anterior resection: is it really temporary? Colorectal Dis. 2010 May;12(5):428-32. doi: 10.1111/j.1463-1318.2009.01815.x. Epub 2009 Feb 17. PMID 19226365
• BACKGROUNDLindgren R, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. What is the risk for a permanent stoma after low anterior resection of the rectum for cancer? A six-year follow-up of a multicenter trial. Dis Colon Rectum. 2011 Jan;54(1):41-7. doi: 10.1007/DCR.0b013e3181fd2948. PMID 21160312
• BACKGROUNDBailey CM, Wheeler JM, Birks M, Farouk R. The incidence and causes of permanent stoma after anterior resection. Colorectal Dis. 2003 Jul;5(4):331-4. doi: 10.1046/j.1463-1318.4.s1.1_78.x. PMID 12814411
• BACKGROUNDden Dulk M, Smit M, Peeters KC, Kranenbarg EM, Rutten HJ, Wiggers T, Putter H, van de Velde CJ; Dutch Colorectal Cancer Group. A multivariate analysis of limiting factors for stoma reversal in patients with rectal cancer entered into the total mesorectal excision (TME) trial: a retrospective study. Lancet Oncol. 2007 Apr;8(4):297-303. doi: 10.1016/S1470-2045(07)70047-5.