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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Survival , Tumor; Stoma; Anal Function; Surgical Anastomosis
• Intervention / Treatment: Procedure: LAR; Procedure: Turnbull-Cutait anastomosis

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quan Wang Professor; Phone Number: +86 15843073207; Email: wquan@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Yuchen Guo; Phone Number: +8613630598312; Email: guoyuchen8688@petalmail.com
    • Changchun, Jilin, China, 130012
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Quan Director; Phone Number: +86 15843073207; Email: wquan@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LAR group; First Surgery; The inferior mesenteric artery is transected at its root.; After mobilization to the levator ani hiatus, surgeons may choose to transect the intestinal tract using a linear cutting stapler under laparoscopy according to the location of the tumor's lower margin. Subsequently, a circular stapler is inserted transanally to perform sigmoid-colorectal anastomosis or sigmoid-anal canal anastomosis.; If the tumor is adjacent to the anal canal, an intersphincteric resection (ISR) is required, and hand-sewn end-to-end sigmoid-anal canal anastomosis is completed transanally.; All patients in the LAR group undergo a protective stoma, which is placed in the right lower quadrant through the rectus abdominis muscle as a loop ileostomy. Second Surgery The stoma reversal surgery for patients in the LAR group should be completed 3 to 6 months after the first surgery.	Procedure: LAR; First Surgery 1. The inferior mesenteric artery is transected at its root. 2. After mobilization to the levator ani hiatus, surgeons may choose to transect the intestinal tract using a linear cutting stapler under laparoscopy according to the location of the tumor's lower margin. Subsequently, a circular stapler is inserted transanally to perform sigmoid-colorectal anastomosis or sigmoid-anal canal anastomosis. 3. If the tumor is adjacent to the anal canal, an intersphincteric resection (ISR) is required, and hand-sewn end-to-end sigmoid-anal canal anastomosis is completed transanally. 4. All patients in the LAR group undergo a protective stoma, which is placed in the right lower quadrant through the rectus abdominis muscle as a loop ileostomy. Second Surgery The stoma reversal surgery for patients in the LAR group should be completed 3 to 4 months after the first surgery.
Experimental: TCA group; First Surgery; Abdominal procedure: The inferior mesenteric artery is ligated at its root. The splenic flexure of the colon is mobilized.; After mobilization to the levator ani hiatus and entry into the intersphincteric space, the procedure switches to transanal operation. The full thickness of the rectal wall is incised 1 cm above the lower edge of the tumor. 5. The rectal tumor and sigmoid colon are pulled out transanally. The sigmoid colon is transected approximately 8 cm above the tumor to complete tumor resection. The distal sigmoid colon is pulled out 4-5 cm through the anus, and the four pre-placed marking sutures are secured to fix sigmoid colon to the anal canal stump. Second Surgery 1. The second surgery for resecting the pulled-out intestinal segment is performed 7-14 days after the first operation. The pulled-out intestinal segment is transected approximately 2 mm caudal to the anal canal stump plane. Subsequently, end-to-end anastomosis is completed.	Procedure: Turnbull-Cutait anastomosis; First Surgery 1. Abdominal procedure: The inferior mesenteric artery is ligated at its root. The splenic flexure of the colon is mobilized. 2. After mobilization to the levator ani hiatus and entry into the intersphincteric space, the procedure switches to transanal operation. The full thickness of the rectal wall is incised 1 cm above the lower edge of the tumor. 5. The rectal tumor and sigmoid colon are pulled out transanally. The sigmoid colon is transected approximately 8 cm above the tumor to complete tumor resection. The distal sigmoid colon is pulled out 4-5 cm through the anus, and the four pre-placed marking sutures are secured to fix sigmoid colon to the anal canal stump. Second Surgery 1. The second surgery for resecting the pulled-out intestinal segment is performed 7-11 days after the first operation. The pulled-out intestinal segment is transected approximately 2 mm caudal to the anal canal stump plane. Subsequently, end-to-end anastomosis is completed.; Other Names: TCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year stoma-free survival postoperatively	The primary endpoint of the present study was 3-year stoma-free survival. An endpoint event was defined as all-cause mortality or the establishment of a permanent, non-reversible intestinal stoma, whichever occurred first within the follow-up period. A non-reversible stoma was stipulated as one that remained unclosed at the completion of the 3-year surveillance interval, at the time of loss to follow-up, or upon patient demise. Individuals who remained event-free but were censored owing to incomplete longitudinal ascertainment were incorporated as censored observations in the subsequent survival analytical paradigm.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS grading	The full name of LARS grading is Low Anterior Resection Syndrome grading, with its core assessment tool being the LARS score (Low Anterior Resection Syndrome score). This grading system categorizes patients into three levels based on the LARS score: no LARS (0-20 points), mild LARS (21-29 points), and severe LARS (30-42 points). It quantifies the severity of intestinal dysfunction following low anterior resection of the rectum, with higher scores indicating more severe dysfunction.	3 months, 6 months, 9 months, 1 year, 2 years, 3 years
Wexner scale	The Wexner scale, formally known as the Wexner Fecal Incontinence Rating Scale, is a commonly used tool for quantitatively assessing the severity of anal incontinence. The scoring range is 0-20 points, with 0 indicating normal and 20 indicating complete incontinence. Higher scores indicate more severe incontinence.	3 months, 6 months, 9 months, 1 year, 2 years, 3 years
Quality of Life Questionnaire (EORTC QLQ-CR29)	The EORTC QLQ-CR29, formally known as the European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire 29 Items, is used to assess health-related quality of life in colorectal cancer patients. The functional dimension score ranges from 0 to 100, with higher scores indicating better functional status. The symptom dimension score also ranges from 0 to 100, with higher scores indicating more severe symptoms.	1 month, 6 months, 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types and Classification of Postoperative Complications	Both surgical complications should be recorded separately, with documentation including the type and severity of complications. Types include infection (incisional infection, pulmonary infection, urinary tract infection, etc.), hemorrhage, organ dysfunction (e.g., cardiac insufficiency, respiratory failure, renal impairment, etc.), anastomotic leakage, thrombosis (deep vein thrombosis, pulmonary embolism, etc.), gastrointestinal dysfunction (e.g., intestinal obstruction, diarrhea, constipation, etc.), and other adverse events directly or indirectly related to the surgery. The severity of complications is typically assessed using the Clavien-Dindo classification system.	3 years
Surgical duration	The duration from the start of the procedure (e.g., skin incision) to the end of the procedure (e.g., completion of suture closure) is recorded in minutes.	From the start of the procedure (e.g., skin incision) to the completion of the surgery (e.g., suturing the incision)
Postoperative hospitalization duration	The postoperative hospitalization duration for both procedures shall be recorded separately. The number of days a patient is hospitalized after surgery is calculated from the end of the procedure until discharge.	Perioperative
Hospitalization expenses	The hospitalization costs for both surgical procedures shall be recorded separately. All medical expenses incurred during the patient's hospitalization period (including the surgical and postoperative recovery phases) shall be documented, covering surgical fees, anesthesia fees, medication fees, examination and testing fees (such as laboratory tests, imaging examinations, etc.), nursing fees, bed fees, medical device usage fees (such as implants, disposable consumables, etc.), and other treatment-related expenses.	Perioperative
Three-year disease-free survival after surgery	The observation window was defined as the period from the randomization date to the time of tumor recurrence in the patient, or death from any cause (whichever occurred first), or the last confirmed date of no recurrence and no death (censored date), with a follow-up period of 3 years after randomization.	3 years
Recurrence rate at 3 years postoperatively	The endpoint event was tumor recurrence in patients or death due to tumor recurrence. It refers to the time from the randomization date until the occurrence of tumor recurrence or death caused by tumor recurrence. Lost to follow-up during the follow-up period and deaths due to non-tumor recurrence causes were treated as censored values.	3 years
Three-year overall survival after surgery	The endpoint event was patient death from any cause. The time from the randomization date to patient death from any cause was calculated. Lost-to-follow-up during follow-up was treated as censored.	3 years

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Collaborators: The First Affiliated Hospital of Zhengzhou University; Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

General Publications

• Yamada K, Ogata S, Saiki Y, Fukunaga M, Tsuji Y, Takano M. Functional results of intersphincteric resection for low rectal cancer. Br J Surg. 2007;94(10):1272-7.
• Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, et al. 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;130:63-71.
• David GG, Slavin JP, Willmott S, Corless DJ, Khan AU, Selvasekar CR. Loop ileostomy following anterior resection: is it really temporary? Colorectal Dis. 2010;12(5):428-32.
• Lindgren R, Hallböök O, Rutegård J, Sjödahl 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;54(1):41-7.
• Bailey CM, Wheeler JM, Birks M, Farouk R. The incidence and causes of permanent stoma after anterior resection. Colorectal Dis. 2003;5(4):331-4.
• den Dulk M, Smit M, Peeters KC, Kranenbarg EM, Rutten HJ, Wiggers T, et al. 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;8(4):297-303.
• Dinnewitzer A, Jäger T, Nawara C, Buchner S, Wolfgang H, Öfner D. Cumulative Incidence of Permanent Stoma After Sphincter Preserving Low Anterior Resection of Mid and Low Rectal Cancer. Diseases of the Colon & Rectum. 2013;56(10):1134-42.
• Jørgensen JB, Erichsen R, Pedersen BG, Laurberg S, Iversen LH. Stoma reversal after intended restorative rectal cancer resection in Denmark: nationwide population-based study. BJS Open. 2020;4(6):1162-71.
• Xu X, Zhong H, You J, Ren M, Fingerhut A, Zheng M, et al. Revolutionizing sphincter preservation in ultra-low rectal cancer: exploring the potential of transanal endoscopic intersphincteric resection (taE-ISR): a propensity score-matched cohort study. Int J Surg. 2024;110(2):709-20.
• Back E, Häggström J, Holmgren K, Haapamäki MM, Matthiessen P, Rutegård J, et al. Permanent stoma rates after anterior resection for rectal cancer: risk prediction scoring using preoperative variables. Br J Surg. 2021;108(11):1388-95.
• Gadan S, Floodeen H, Lindgren R, Rutegård M, Matthiessen P. What is the risk of permanent stoma beyond 5 years after low anterior resection for rectal cancer? A 15-year follow-up of a randomized trial. Colorectal Dis. 2020;22(12):2098-104.
• Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, et al. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024;159(9):990-6.
• Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, et al. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020;155(8):e201625.
• La Raja C, Foppa C, Maroli A, Kontovounisios C, Ben David N, Carvello M, et al. Surgical outcomes of Turnbull-Cutait delayed coloanal anastomosis with pull-through versus immediate coloanal anastomosis with diverting stoma after total mesorectal excision for low rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2022;26(8):603-13.
• Beirens K, Penninckx F. Defunctioning stoma and anastomotic leak rate after total mesorectal excision with coloanal anastomosis in the context of PROCARE. Acta Chir Belg. 2012;112(1):10-4.
• Guo Y, He L, Tong W, Ren S, Chi Z, Tan K, et al. Intersphincteric resection following robotic-assisted versus laparoscopy-assisted total mesorectal excision for middle and low rectal cancer: a multicentre propensity score analysis of 1571 patients. Int J Surg. 2024;110(4):1904-12.
• Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg. 1994;81(9):1376-8.
• Rullier E, Denost Q, Vendrely V, Rullier A, Laurent C. Low rectal cancer: classification and standardization of surgery. Dis Colon Rectum. 2013;56(5):560-7.
• Parks AG. Transanal technique in low rectal anastomosis. Proc R Soc Med. 1972;65(11):975-6.
• Cutait DE, Figliolini FJ. A new method of colorectal anastomosis in abdominoperineal resection. Diseases of the Colon & Rectum. 1961;4(5):335-42.
• Turnbull RB, Cuthbertson A. Abdominorectal Pull-Through Resection for Cancer and for Hirschsprung's Disease. Delayed Posterior Colorectal Anastomosis. 1961;28(2):109-15.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rectal neoplasms; Low anterior resection; Turnbull-Cutait anastomosis; Stoma-free survival
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: FIAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No