Turnbull-Cutait versus low anterior resection to avoid a permanent stoma in low rectal cancer
The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery: A Multicenter Randomized Controlled Trial (FIAS)
This study will try whether Turnbull-Cutait delayed coloanal anastomosis or low anterior resection with a protective stoma better keeps adults with low rectal cancer stoma-free over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Locations | 2 sites (Changchun, Jilin and 1 other locations) |
| Trial ID | NCT07369531 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 with biopsy-proven low rectal adenocarcinoma (tumor ≤5 cm from the anal margin), no distant metastases, MRI staging meeting the protocol's cT/cN/MRF criteria, BMI <28 kg/m², and fit for laparoscopic or robot-assisted radical surgery.
Not a fit: Patients with distant metastases, tumor invasion of the external anal sphincter, BMI ≥28 kg/m², those outside the 18–75 age range, or those unable to undergo the specified surgical approaches are unlikely to benefit from these procedures within this protocol.
Why it matters
Potential benefit: If successful, the Turnbull-Cutait approach could reduce permanent stoma rates and improve bowel function and quality of life for people with low rectal cancer.
How similar studies have performed: The Turnbull-Cutait delayed anastomosis has been reported in surgical series to lower permanent stoma rates and preserve function in selected patients, but high-quality randomized comparisons with LAR are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changchun, Jilin and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.