Turnbull-Cutait versus low anterior resection to avoid a permanent stoma in low rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two surgical methods — Turnbull-Cutait delayed coloanal anastomosis (TCA) and low anterior resection with a protective stoma (LAR) — in patients with low rectal adenocarcinoma. The primary outcome is 3-year stoma-free survival, with additional measurement of postoperative anal function (LARS and Wexner scores), quality of life (EORTC QLQ-CR29), surgical complications, pathological results, and survival outcomes. Eligible patients are adults 18–75 with tumors within 5 cm of the anal margin, no distant metastases, specified MRI staging, BMI <28 kg/m², and suitable for laparoscopic or robot-assisted radical surgery. Surgeries and follow-up are performed at participating hospitals in China with outcome data collected through at least one year and the primary endpoint at three years.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Quan Wang Professor
• Email: wquan@jlu.edu.cn
• Phone: +86 15843073207

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.