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

NCT07369531 | Recruiting DMC

• 1 other identifier: FIAS
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer?
2. 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.
3. 3.Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio.
4. 4.Receive the corresponding surgical intervention.
5. 5.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.
6. 6.Provide relevant clinical data (perioperative, pathological, follow-up) as required.

Conditions

Rectal Cancer; Surgical Anastomosis; Survival , Tumor; Anal Function; Stoma

Keywords

Turnbull-Cutait anastomosis; Rectal neoplasms; Low anterior resection; Stoma-free survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• LARS grading

  3 months, 6 months, 9 months, 1 year, 2 years, 3 years

• Wexner scale

  3 months, 6 months, 9 months, 1 year, 2 years, 3 years

• Quality of Life Questionnaire (EORTC QLQ-CR29)

  1 month, 6 months, 1 year

Other Outcomes (7)

• Types and Classification of Postoperative Complications

  3 years

• Surgical duration

  From the start of the procedure (e.g., skin incision) to the completion of the surgery (e.g., suturing the incision)

• Postoperative hospitalization duration

  Perioperative

Study Arms (2)

LAR group

ACTIVE COMPARATOR

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 6 months after the first surgery.

Procedure: LAR

TCA group

EXPERIMENTAL

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 7-14 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

Interventions

Turnbull-Cutait anastomosis PROCEDURE

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.

Also known as: TCA

TCA group

LAR PROCEDURE

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.

LAR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
• Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
• 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;
• 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;
• Preoperative BMI \< 28 kg/m²
• Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).

You may not qualify if:

• Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
• History of previous open surgery (non-minimally invasive procedures);
• Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor;
• Pregnant patients or those with concurrent inflammatory bowel disease;
• Preoperative patients with complete intestinal obstruction or requiring emergency surgery;
• Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.;
• Recent treatment for other malignancies;
• Low rectal cancer classified as type IV in the Bordeaux classification system;
• Intraoperatively confirmed distant metastatic disease
• Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma.
• Withdrawal Criteria
• Patients who refuse surgical intervention after randomization.
• Patients who undergo an abdominoperineal resection (APR) following randomization.
• Patients who request voluntary withdrawal from the trial at any time throughout the study period.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (2)

First Hospital of Jilin University

Changchun, Jilin, 130012, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Related Publications (21)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Parks AG. Transanal technique in low rectal anastomosis. Proc R Soc Med. 1972;65(11):975-6.

  BACKGROUND

• Cutait DE, Figliolini FJ. A new method of colorectal anastomosis in abdominoperineal resection. Diseases of the Colon &amp; Rectum. 1961;4(5):335-42.

  BACKGROUND

• Turnbull RB, Cuthbertson A. Abdominorectal Pull-Through Resection for Cancer and for Hirschsprung's Disease. Delayed Posterior Colorectal Anastomosis. 1961;28(2):109-15.

  BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Quan Wang Professor

CONTACT

+86 15843073207; wquan@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 27, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

CN (2)