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Rectal CancerFIASNCT07369531

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

A study testing Turnbull-Cutait anastomosis and LAR in people with Rectal Cancer and Surgical Anastomosis, run by The First Hospital of Jilin University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Turnbull-Cutait anastomosis and LAR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
2 sitesChina
Study dates
18 Mar 2026to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.;
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Quan Wang Professor contact

+86 15843073207

wquan@jlu.edu.cn

China2 sites, 2 recruiting

  • First Hospital of Jilin University

    Changchun, Jilin, 130012

    Quan Director, +86 15843073207, wquan@jlu.edu.cn

    Recruiting

  • First Hospital of Jilin University

    Changchun, Jilin, 130021

    Yuchen Guo, +8613630598312, guoyuchen8688@petalmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.
Read more

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.
Being tested
Turnbull-Cutait anastomosis, LAR
Keywords
Turnbull-Cutait anastomosis, Rectal neoplasms, Low anterior resection, Stoma-free survival
Medical subject headings
Rectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Turnbull-Cutait anastomosisProcedure or surgery

    Also called TCA

    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.

  • LARProcedure or surgery

    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.

Study groups in NCT07369531
Study groupRoleWhat they receive
LAR groupActive comparatorFirst 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.
Receives: Procedure: LAR
TCA groupExperimentalFirst 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.
Receives: Procedure: Turnbull-Cutait anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (3)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: 1 month, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start18 Mar 2026
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07369531
Sponsor's protocol ID
FIAS
Acronym
FIAS
Status last verified
Mar 2026
First submitted
28 Dec 2025
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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 Oct;94(10):1272-7. doi: 10.1002/bjs.5534.

    PubMed 17671960

  • Cohen 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.

    PubMed 32172199

  • David 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.

    PubMed 19226365

  • Lindgren 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.

    PubMed 21160312

  • Bailey 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.

    PubMed 12814411

  • den 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.

    PubMed 17395102

  • Dinnewitzer A, Jager T, Nawara C, Buchner S, Wolfgang H, Ofner D. Cumulative incidence of permanent stoma after sphincter preserving low anterior resection of mid and low rectal cancer. Dis Colon Rectum. 2013 Oct;56(10):1134-42. doi: 10.1097/DCR.0b013e31829ef472.

    PubMed 24022530

  • Jorgensen 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 Oct 6;4(6):1162-71. doi: 10.1002/bjs5.50340. Online ahead of print.

    PubMed 33022143

  • Xu X, Zhong H, You J, Ren M, Fingerhut A, Zheng M, Li J, Yang X, Song H, Zhang S, Ding C, Abuduaini N, Yu M, Liu J, Zhang Y, Kang L, Cai Z, Feng B. 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 Feb 1;110(2):709-720. doi: 10.1097/JS9.0000000000000945.

    PubMed 38016136

  • Back E, Haggstrom J, Holmgren K, Haapamaki MM, Matthiessen P, Rutegard J, Rutegard M. Permanent stoma rates after anterior resection for rectal cancer: risk prediction scoring using preoperative variables. Br J Surg. 2021 Nov 11;108(11):1388-1395. doi: 10.1093/bjs/znab260.

    PubMed 34508549

  • Gadan S, Floodeen H, Lindgren R, Rutegard 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 Dec;22(12):2098-2104. doi: 10.1111/codi.15364. Epub 2020 Oct 24.

    PubMed 32931137

  • Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262.

    PubMed 38985480

  • Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19.

    PubMed 32492131

  • La Raja C, Foppa C, Maroli A, Kontovounisios C, Ben David N, Carvello M, Spinelli A. 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 Aug;26(8):603-613. doi: 10.1007/s10151-022-02601-4. Epub 2022 Mar 28.

    PubMed 35344150

  • Beirens K, Penninckx F; PROCARE. Defunctioning stoma and anastomotic leak rate after total mesorectal excision with coloanal anastomosis in the context of PROCARE. Acta Chir Belg. 2012 Jan;112(1):10-4. doi: 10.1080/00015458.2012.11680789.

    PubMed 22442904

Questions about this trial

What is this clinical trial studying?

A study testing Turnbull-Cutait anastomosis and LAR in people with Rectal Cancer and Surgical Anastomosis, run by The First Hospital of Jilin University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Quan Wang Professor (+86 15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year stoma-free survival postoperatively (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07369531, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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