Rectal CancerSTAR-TARNCT06662643
A Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
A study testing Delayed transanal pull-through anastomosis and Direct Anastomosis Plus Prophylactic Ileostomy in people with Rectal Cancer and Rectal Carcinoma, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study targets patients undergoing ultra-low rectal cancer surgery, which requires internal sphincter resection for sphincter-saving procedures. The study compares the staged Turnbull-Cutait Pull-through anastomosis (a delayed transanal pull-through anastomosis without a protective stoma) as the experimental group… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Rectal Carcinoma
- What is being tested?
- Delayed transanal pull-through anastomosis and Direct Anastomosis Plus Prophylactic Ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 30 Dec 2029
- 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
- Histopathologically confirmed high- or moderate-grade adenocarcinoma or villous adenoma with malignancy on preoperative colonoscopy; tumor located ≤ 5 cm from the anal verge; primary tumor size < 5 cm in diameter.
- All enrolled patients require intersphincteric dissection. PISR surgery must be completed with hand-sewn (preferably) or stapled coloanal anastomosis. The anastomosis should be located near the dentate line (intraoperative photos or videos must be preserved).
- Both male and female patients aged 18-75.
- Non-recurrent rectal cancer.
- No concurrent multiple primary colorectal cancers.
- Initial staging or post-neoadjuvant therapy stage: T3 above the levator ani, T1-2 below.
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- Liver or lung oligometastases deemed resectable after evaluation by a multidisciplinary team (MDT).
- Patients may or may not have received neoadjuvant chemoradiotherapy.
- Patients and families must understand and be willing to participate in this study, providing written informed consent.
- Good anal function (Wexner incontinence score ≤ 5).
Who cannot join
- History of malignant colorectal tumors.
- Previous colorectal or anorectal surgeries or diseases.
- Patients requiring emergency surgery due to intestinal obstruction, perforation, or bleeding.
- Tumor invasion into the external sphincter, levator ani, or adjacent organs requiring combined organ resection.
- Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).
- History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP).
Show all 14Show fewer
- Recent diagnosis of other malignancies.
- Participation in other clinical trials within the 4 weeks prior to enrollment.
- ASA classification ≥ IV or ECOG performance status ≥ 2.
- Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction or serious underlying disease precluding surgery.
- History of severe mental illness.
- Pregnant or breastfeeding women.
- Uncontrolled preoperative infection.
- Other clinical or laboratory findings making the patient unsuitable for the study, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430067
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
This study targets patients undergoing ultra-low rectal cancer surgery, which requires internal sphincter resection for sphincter-saving procedures. The study compares the staged Turnbull-Cutait Pull-through anastomosis (a delayed transanal pull-through anastomosis without a protective stoma) as the experimental group with traditional anastomosis (hand-sewn/stapled) plus protective ileostomy as the control group. The aim is to assess whether the Turnbull-Cutait Pull-through colon-anal anastomosis is non-inferior to traditional ISR surgery in terms of complications (short-term such as anastomotic leakage/dehiscence, pelvic infection, anastomotic bleeding, ischemic bowel necrosis, bowel obstruction, and long-term complications such as anastomotic stricture, perianastomotic fistula, bowel obstruction, stoma-related complications, and others), postoperative anal function, quality of life, long-term oncologic outcomes, hospital stay duration, and total hospitalization costs.
Read the detailed description
In recent years, with the increasing understanding of the anatomy and physiological functions of the lower rectum, the biological behavior of rectal cancer tumors, advancements in new surgical technologies, and the application of comprehensive treatment methods, there has been growing emphasis on radical surgical procedures for low rectal cancer that balance oncological safety with anal function preservation. After undergoing total mesorectal excision for low rectal cancer and subsequent coloanal anastomosis, patients often face a high risk of anastomotic leakage and pelvic infection. Therefore, a protective ileostomy is usually performed to divert feces, providing a relatively low-perfusion environment conducive to healing for ultra-low coloanal anastomoses. In the event of an anastomotic leak, the protective stoma can mitigate infection and reduce the likelihood of secondary surgeries. Nevertheless, complications following protective ileostomy, such as dehydration, chronic renal failure, and parastomal hernia, occur at rates as high as 43% . Additionally, complications related to stoma reversal exceed 20% , all of which significantly impact patients' quality of life. Approximately one-fifth of patients with preventive stomas are unable to have their stomas reversed as planned, or may require lifelong stoma formation.
In 1961, Turnbull and Cutait independently reported surgical techniques involving transanal pull-through rectal resection and delayed manual coloanal anastomosis. From a certain perspective, this procedure is the safest reconstructive method, effectively reducing anastomotic leakage-related complications and avoiding the need for a protective stoma. In recent years, its clinical application in challenging rectal cases involving radiation proctitis, complex recto-vaginal/urethral fistulas, salvage surgeries for anastomotic leaks, and low-stage progressive rectal cancer has gained increasing attention and acceptance.In 2020, a multicenter randomized controlled study published in JAMA Surgery found that the delayed anastomosis group (avoiding protective stoma) did not increase the incidence of anastomotic leaks or other complications compared to the standard coloanal anastomosis plus ileostomy group, and exhibited comparable oncological and functional outcomes . Furthermore, a recent systematic review in 2022 included one randomized controlled trial and nine observational studies with a total of 1,743 patients. This study found that staged Turnbull-Cutait anastomosis was associated with a reduced rate of anastomotic leaks.
However, the aforementioned studies and systematic reviews on staged Turnbull-Cutait anastomosis were all based on total mesorectal excision (TME), and there is a paucity of data on postoperative anal function and quality of life following this procedure, necessitating further research. As an extreme sphincter-saving surgery, ISR is currently limited in widespread adoption due to the high incidence of postoperative complications and suboptimal functional outcomes associated with anastomoses located very close to the anal verge. To date, there is a lack of systematic studies applying the Turnbull-Cutait Pull-through anastomosis to ISR procedures. Therefore, it is highly worthwhile to conduct a multicenter prospective randomized controlled study to determine whether the modified Bacon procedure (transanal pull-through, delayed anastomosis) can serve as an effective alternative to ISR-coloanal anastomosis, achieving comparable or lower rates of postoperative complications, as well as equivalent oncological radicality and defecatory function. Such research is urgently needed in this largely unexplored field. If successfully conducted and achieving its objectives, this clinical study could provide highly valuable guidance for clinical practice. Existing reports on the application of the modified Bacon procedure in low rectal cancer are generally small-sample, single-center, retrospective studies with low levels of evidence. This study aims to provide higher-level evidence through a larger-sample, prospective, multicenter, randomized controlled design.
- Conditions
- Rectal Cancer, Rectal Carcinoma
- Being tested
- Delayed transanal pull-through anastomosis, Direct Anastomosis Plus Prophylactic Ileostomy
- Keywords
- Low Rectal Cancer, Turnbull-Cutait, Pull-through, Internal Sphincter Resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed transanal pull-through anastomosisProcedure or surgery
Laparoscopic surgery is recommended. A standard 5-port method is used to create pneumoperitoneum after placing the trocar. The sigmoid colon and upper rectal mesentery are dissected along Toldt's fascia. Autonomic nerves should be preserved, and high ligation of the inferior mesenteric vessels with lymph node dissection is recommended. TME: Using a posterior-to-anterior approach, the mesorectal plane is dissected down to the pelvic floor, cutting the Waldeyer's fascia to enter the intersphincteric space, where sharp dissection is carried out toward the levator ani muscle hiatus. The dissection endpoint is the dentate line, where the proximal colon is exteriorized by at least 2 cm and sutured to the anal canal with 6-8 stitches, without a protective ileostomy.Two to four weeks after the first surgery, after the colon has adhered well to the surrounding tissue, the exteriorized colon is excised (under epidural or spinal anesthesia, trimming the exteriorized colon to form the anus).
Direct Anastomosis Plus Prophylactic IleostomyProcedure or surgery
ISR is categorized into partial ISR (PISR), subtotal ISR, and total ISR (TISR). Correspondingly, the anastomosis site after coloanal anastomosis is located below the levator ani hiatus (PISR, near the dentate line; subtotal-ISR and TISR, below the dentate line).The dissection steps are the same as in the first stage of the Staged Turnbull-Cutait Pull-through Anastomosis group (TME and intersphincteric space dissection).The bowel is transected at least 1 cm below the tumor, leaving a larger segment of healthy tissue on the non-tumor side while ensuring that no more than 1/3 of the dentate line is resected to avoid impairing fecal control.Anastomosis is performed using absorbable sutures under direct visualization. A protective ileostomy is created 25-30 cm from the ileocecal valve.3 to 6 months after surgery, the ileostomy is reversed. Prior to closure, digital rectal examination, defecography, MRI, colonoscopy, and other evaluation must perform.
| Study group | Role | What they receive |
|---|---|---|
| Staged Turnbull-Cutait Pull-through anastomosis group | Experimental | Participants in this group will undergo staged Turnbull-Cutait pull-through anastomosis for the treatment of low rectal cancer after internal sphincter resection. Receives: Procedure: Delayed transanal pull-through anastomosis |
| Direct anastomosis plus protective ileostomy group | Active comparator | Participants in this group will receive direct anastomosis combined with a prophylactic ileostomy. Receives: Procedure: Direct Anastomosis Plus Prophylactic Ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Overall Composite Postoperative Complication Rate
30-day overall composite postoperative complication rate includes anastomotic leakage/dehiscence, bleeding, ischemic bowel necrosis, pelvic infection (abscess), pelvic bleeding, bowel obstruction, stoma-related complications, and other complications occurring within 30 days. Anastomotic leakage is defined according to the criteria proposed by the International Study Group of Rectal Cancer (ISREC) in 2010, graded as A, B, or C, depending on severity and management.
Measured: postoperative 30 days
Secondary outcomes (11)
Long-term Complications Rate
These include anastomotic stricture, anastomotic fistulas (e.g., rectovaginal or rectourethral fistula), bowel obstruction, stoma-related complications, inability to reverse stoma, chronic presacral sinus, and rectal prolapse (both mucosal and full-thickness).
Measured: postoperative 2 years
Total Surgery Time
Defined as the combined time of the two stages (Phase 1 + Phase 2) of Staged Turnbull-Cutait Pull-through Anastomosis with Direct Anastomosis or intersphincteric resection (ISR) plus stoma reversal time. This also includes total hospital stay (Phase 1 + Phase 2) and total hospitalization costs (Phase 1 + Phase 2).
Measured: postoperative 1 years
LARS Score Questionnaire
Low Anterior Resection Syndrome (LARS) Score is a tool used to assess bowel function after surgical treatment for rectal cancer, particularly following low anterior resection (LAR) procedures. The LARS score evaluates the presence and severity of bowel dysfunction, which can significantly impact the quality of life for patients.
Minimum Value: 0 Maximum Value: 42 Interpretation: Higher scores indicate worse bowel function and greater symptoms of LARS.
Measured: Every 6 months in the postoperative 3 years
Wexner Incontinence Score
The Wexner Incontinence Score, is a validated tool used to assess the severity of fecal incontinence in patients. The Wexner score is calculated by summing the scores from each of the categories:0: No incontinence；1-5: Mild incontinence；6-10: Moderate incontinence；11-20: Severe incontinence Minimum Value: 0 Maximum Value: 20 Interpretation: Higher scores indicate worse fecal incontinence and greater impact on quality of life.
Measured: Every 6 months in the postoperative 3 years
International Prostate Symptom Score (IPSS) Questionnaire
The International Prostate Symptom Score (IPSS) is a widely used tool for evaluating the severity of urinary symptoms in men and helps to assess the impact of these symptoms on patients' quality of life.
Minimum Value: 0 Maximum Value: 35 Interpretation: Higher scores indicate worse urinary symptoms and a greater impact on quality of life.
Measured: Every 6 months in the postoperative 3 years
The Fecal Incontinence Quality of Life Scale (FIQL).
Quality of Life
Measured: Every 6 months in the postoperative 3 years
International Index of Erectile Function (IIEF-5) Questionnaire
The International Index of Erectile Function (IIEF-5) is a widely used questionnaire designed to assess erectile function in men. IIEF-5 consists of five questions that evaluate different aspects of erectile function. Each question is scored on a scale from 0 to 5, with higher scores indicating better erectile function.
Minimum Value: 0 Maximum Value: 25 Interpretation: Higher scores indicate better erectile function and greater sexual satisfaction.
Measured: Every 6 months in the postoperative 3 years
Female Sexual Function Index (FSFI) Questionnaire
The Female Sexual Function Index (FSFI) is a widely used questionnaire designed to assess various dimensions of female sexual function. It is a reliable tool for identifying sexual dysfunction in women.
Minimum Value: 2 Maximum Value: 36 Interpretation: Higher scores indicate better sexual function. A total score below 26.55 suggests the presence of sexual dysfunction.
Measured: Every 6 months in the postoperative 3 years
EORTC QLQ-CR29 Questionnaire
The EORTC QLQ-CR29 is a specific quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life in patients with colorectal cancer. This questionnaire is an extension of the EORTC Quality of Life Questionnaire (QLQ-C30) and is designed to evaluate the specific concerns and symptoms experienced by colorectal cancer patients.
Number of Items: 29 Scoring Range: 0 to 100 Interpretation: Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales.
Measured: Every 6 months in the postoperative 3 years
3-year Disease-Free Survival (3-year DFS)
3-year DFS refers to the duration during which patients remain free of disease following treatment (such as surgery, chemotherapy, or radiation) for a period of three years.Expressed as a percentage, with a higher percentage indicating that a greater proportion of patients remain disease-free at the 3-year mark, suggesting that the treatment may be effective in preventing recurrence or progression.Local recurrence is defined as evidence of recurrence within the pelvic area detected through digital rectal examination, colonoscopy, CT/MRI, PET-CT, or biopsy (when necessary) and confirmed to match the histopathology of the primary tumor. Distant metastasis is defined as evidence of metastasis found outside the pelvic area, including the liver, lungs, bones, or para-aortic lymph nodes.
Measured: postoperative 3 years
3-year Overall Survival (3-year OS)
Refers to the proportion of patients who remain alive three years after the beginning of the study period.Reported as a percentage, with a higher percentage indicating a greater proportion of patients alive at the 3-year mark, which may reflect improved survival due to the treatment.
Measured: postoperative 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start8 May 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ezhou Central Hospital, Jingzhou Central Hospital, Taihe Hospital, Hubei University of Medicine, Qilu Hospital of Shandong University, Beijing Chao Yang Hospital, Tianmen First People's Hospital, Xiangyang Central Hospital, First People's Hospital of Xianyang, Central Hospital of Xiaogan, Yichang Central People's Hospital, Yichang Second People's Hospital, Rocket Force Special Medical Center of the People's Liberation Army, Huashan Hospital
- Responsible party
- Principal investigator, Congqing Jiang, Zhongnan Hospital
- Investigators
- Congqing Jiang, MD, PhD, Principal investigator, Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662643
- Sponsor's protocol ID
- Zhongnan Hospital Wuhan
- Other IDs
- 2024054
- Acronym
- STAR-TAR
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://www.medresman.org.cn/login.aspx http://www.medresman.org.cn/html/resman.pdf The Clinical Research Public Management Platform (Research Manager, ResMan) is an Electronic Data Capture (EDC) system that manages the clinical trial processes and records all relevant information, including baseline data of subjects such as demographic information, baseline data collected during enrollment, implementation details during the trial, and outcome data, encapsulated in the Case Record Form (CRF). All this information is recorded online via the internet and transmitted to a central database for management. Only researchers from the study group are allowed to access and operate the trial, while project managers, sponsors, or investors of funded projects have the right to view real-time data but cannot make any changes. Researchers decide whether to disclose research result data. Once data is entered and saved, any subsequent changes are automatically displayed and tracked.
Publications
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 35344150Biondo 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 32492131Portale G, Popesc GO, Parotto M, Cavallin F. Delayed Colo-anal Anastomosis for Rectal Cancer: Pelvic Morbidity, Functional Results and Oncological Outcomes: A Systematic Review. World J Surg. 2019 May;43(5):1360-1369. doi: 10.1007/s00268-019-04918-y.
PubMed 30690655Remzi FH, El Gazzaz G, Kiran RP, Kirat HT, Fazio VW. Outcomes following Turnbull-Cutait abdominoperineal pull-through compared with coloanal anastomosis. Br J Surg. 2009 Apr;96(4):424-9. doi: 10.1002/bjs.6458.
PubMed 19283735Patsouras D, Yassin NA, Phillips RK. Clinical outcomes of colo-anal pull-through procedure for complex rectal conditions. Colorectal Dis. 2014 Apr;16(4):253-8. doi: 10.1111/codi.12532.
PubMed 24344638TURNBULL RB Jr, CUTHBERTSON A. Abdominorectal pull-through resection for cancer and for Hirschsprung's disease. Delayed posterior colorectal anastomosis. Cleve Clin Q. 1961 Apr;28:109-15. doi: 10.3949/ccjm.28.2.109. No abstract available.
PubMed 13778709CUTAIT DE, FIGLIOLINI FJ. A new method of colorectal anastomosis in abdominoperineal resection. Dis Colon Rectum. 1961 Sep-Oct;4:335-42. doi: 10.1007/BF02627230. No abstract available.
PubMed 13882795Man VC, Choi HK, Law WL, Foo DC. Morbidities after closure of ileostomy: analysis of risk factors. Int J Colorectal Dis. 2016 Jan;31(1):51-7. doi: 10.1007/s00384-015-2327-2. Epub 2015 Aug 6.
PubMed 26245947Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.
PubMed 31061647Martin ST, Heneghan HM, Winter DC. Systematic review of outcomes after intersphincteric resection for low rectal cancer. Br J Surg. 2012 May;99(5):603-12. doi: 10.1002/bjs.8677. Epub 2012 Jan 13.
PubMed 22246846Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg. 1994 Sep;81(9):1376-8. doi: 10.1002/bjs.1800810944.
PubMed 7953423Chen W, Ding J, Xiang J, Wang Y, Han J, Ye H, Wang D, Lin B, Lei J, Wu X, Di M, Fu Y, Yang G, Qin C, Chen A, Xu J, Liu W, Jiang C; STAR-TAR study group. Staged Turnbull-Cutait pull-through anastomosis comparing with direct anastomosis plus prophylactic ileostomy in the treatment of low rectal cancer after internal sphincter resection (STAR-TAR): study protocol for a randomized controlled trial. Trials. 2025 May 22;26(1):168. doi: 10.1186/s13063-025-08845-3.
PubMed 40405283
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
- ClinicalTrials.gov ID
- NCT06662643
- Acronym / sponsor ID
- STAR-TAR / Zhongnan Hospital Wuhan
- Conditions
- Rectal Cancer, Rectal Carcinoma
- Keywords
- Low Rectal Cancer, Turnbull-Cutait, Pull-through, Internal Sphincter Resection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Collaborators
- Ezhou Central Hospital, Jingzhou Central Hospital, Taihe Hospital, Hubei University of Medicine, Qilu Hospital of Shandong University, Beijing Chao Yang Hospital, Tianmen First People's Hospital, Xiangyang Central Hospital, First People's Hospital of Xianyang, Central Hospital of Xiaogan, Yichang Central People's Hospital, Yichang Second People's Hospital, Rocket Force Special Medical Center of the People's Liberation Army, Huashan Hospital
- Study start
- 8 May 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study targets patients undergoing ultra-low rectal cancer surgery, which requires internal sphincter resection for sphincter-saving procedures. The study compares the staged Turnbull-Cutait Pull-through anastomosis (a delayed transanal pull-through anastomosis without a protective stoma) as the experimental group with traditional anastomosis (hand-sewn/stapled) plus protective ileostomy as the control group. The aim is to assess whether the Turnbull-Cutait Pull-through colon-anal anastomosis is non-inferior to traditional ISR surgery in terms of complications (short-term such as anastomotic leakage/dehiscence, pelvic infection, anastomotic bleeding, ischemic bowel necrosis, bowel obstruction, and long-term complications such as anastomotic stricture, perianastomotic fistula, bowel obstruction, stoma-related complications, and others), postoperative anal function, quality of life, long-term oncologic outcomes, hospital stay duration, and total hospitalization costs.
Detailed description
In recent years, with the increasing understanding of the anatomy and physiological functions of the lower rectum, the biological behavior of rectal cancer tumors, advancements in new surgical technologies, and the application of comprehensive treatment methods, there has been growing emphasis on radical surgical procedures for low rectal cancer that balance oncological safety with anal function preservation. After undergoing total mesorectal excision for low rectal cancer and subsequent coloanal anastomosis, patients often face a high risk of anastomotic leakage and pelvic infection. Therefore, a protective ileostomy is usually performed to divert feces, providing a relatively low-perfusion environment conducive to healing for ultra-low coloanal anastomoses. In the event of an anastomotic leak, the protective stoma can mitigate infection and reduce the likelihood of secondary surgeries. Nevertheless, complications following protective ileostomy, such as dehydration, chronic renal failure, and parastomal hernia, occur at rates as high as 43% . Additionally, complications related to stoma reversal exceed 20% , all of which significantly impact patients' quality of life. Approximately one-fifth of patients with preventive stomas are unable to have their stomas reversed as planned, or may require lifelong stoma formation.
In 1961, Turnbull and Cutait independently reported surgical techniques involving transanal pull-through rectal resection and delayed manual coloanal anastomosis. From a certain perspective, this procedure is the safest reconstructive method, effectively reducing anastomotic leakage-related complications and avoiding the need for a protective stoma. In recent years, its clinical application in challenging rectal cases involving radiation proctitis, complex recto-vaginal/urethral fistulas, salvage surgeries for anastomotic leaks, and low-stage progressive rectal cancer has gained increasing attention and acceptance.In 2020, a multicenter randomized controlled study published in JAMA Surgery found that the delayed anastomosis group (avoiding protective stoma) did not increase the incidence of anastomotic leaks or other complications compared to the standard coloanal anastomosis plus ileostomy group, and exhibited comparable oncological and functional outcomes . Furthermore, a recent systematic review in 2022 included one randomized controlled trial and nine observational studies with a total of 1,743 patients. This study found that staged Turnbull-Cutait anastomosis was associated with a reduced rate of anastomotic leaks.
However, the aforementioned studies and systematic reviews on staged Turnbull-Cutait anastomosis were all based on total mesorectal excision (TME), and there is a paucity of data on postoperative anal function and quality of life following this procedure, necessitating further research. As an extreme sphincter-saving surgery, ISR is currently limited in widespread adoption due to the high incidence of postoperative complications and suboptimal functional outcomes associated with anastomoses located very close to the anal verge. To date, there is a lack of systematic studies applying the Turnbull-Cutait Pull-through anastomosis to ISR procedures. Therefore, it is highly worthwhile to conduct a multicenter prospective randomized controlled study to determine whether the modified Bacon procedure (transanal pull-through, delayed anastomosis) can serve as an effective alternative to ISR-coloanal anastomosis, achieving comparable or lower rates of postoperative complications, as well as equivalent oncological radicality and defecatory function. Such research is urgently needed in this largely unexplored field. If successfully conducted and achieving its objectives, this clinical study could provide highly valuable guidance for clinical practice. Existing reports on the application of the modified Bacon procedure in low rectal cancer are generally small-sample, single-center, retrospective studies with low levels of evidence. This study aims to provide higher-level evidence through a larger-sample, prospective, multicenter, randomized controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged Turnbull-Cutait Pull-through anastomosis group | Experimental | Procedure: Delayed transanal pull-through anastomosisParticipants in this group will undergo staged Turnbull-Cutait pull-through anastomosis for the treatment of low rectal cancer after internal sphincter resection. |
| Direct anastomosis plus protective ileostomy group | Active comparator | Procedure: Direct Anastomosis Plus Prophylactic IleostomyParticipants in this group will receive direct anastomosis combined with a prophylactic ileostomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologically confirmed high- or moderate-grade adenocarcinoma or villous adenoma with malignancy on preoperative colonoscopy; tumor located ≤ 5 cm from the anal verge; primary tumor size < 5 cm in diameter.
- All enrolled patients require intersphincteric dissection. PISR surgery must be completed with hand-sewn (preferably) or stapled coloanal anastomosis. The anastomosis should be located near the dentate line (intraoperative photos or videos must be preserved).
- Both male and female patients aged 18-75.
- Non-recurrent rectal cancer.
- No concurrent multiple primary colorectal cancers.
Key exclusion criteria (14 listed)
- History of malignant colorectal tumors.
- Previous colorectal or anorectal surgeries or diseases.
- Patients requiring emergency surgery due to intestinal obstruction, perforation, or bleeding.
- Tumor invasion into the external sphincter, levator ani, or adjacent organs requiring combined organ resection.
- Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed transanal pull-through anastomosisLaparoscopic surgery is recommended. A standard 5-port method is used to create pneumoperitoneum after placing the trocar. The sigmoid colon and upper rectal mesentery are dissected along Toldt's fascia. Autonomic nerves should be preserved, and high ligation of the inferior mesenteric vessels with lymph node dissection is recommended. TME: Using a posterior-to-anterior approach, the mesorectal plane is dissected down to the pelvic floor, cutting the Waldeyer's fascia to enter the intersphincteric space, where sharp dissection is carried out toward the levator ani muscle hiatus. The dissection endpoint is the dentate line, where the proximal colon is exteriorized by at least 2 cm and sutured to the anal canal with 6-8 stitches, without a protective ileostomy.Two to four weeks after the first surgery, after the colon has adhered well to the surrounding tissue, the exteriorized colon is excised (under epidural or spinal anesthesia, trimming the exteriorized colon to form the anus). | Procedure or surgery | Staged Turnbull-Cutait Pull-through anastomosis group |
| Direct Anastomosis Plus Prophylactic IleostomyISR is categorized into partial ISR (PISR), subtotal ISR, and total ISR (TISR). Correspondingly, the anastomosis site after coloanal anastomosis is located below the levator ani hiatus (PISR, near the dentate line; subtotal-ISR and TISR, below the dentate line).The dissection steps are the same as in the first stage of the Staged Turnbull-Cutait Pull-through Anastomosis group (TME and intersphincteric space dissection).The bowel is transected at least 1 cm below the tumor, leaving a larger segment of healthy tissue on the non-tumor side while ensuring that no more than 1/3 of the dentate line is resected to avoid impairing fecal control.Anastomosis is performed using absorbable sutures under direct visualization. A protective ileostomy is created 25-30 cm from the ileocecal valve.3 to 6 months after surgery, the ileostomy is reversed. Prior to closure, digital rectal examination, defecography, MRI, colonoscopy, and other evaluation must perform. | Procedure or surgery | Direct anastomosis plus protective ileostomy group |
Primary outcome
30-Day Overall Composite Postoperative Complication Rate
Time frame: postoperative 30 days
30-day overall composite postoperative complication rate includes anastomotic leakage/dehiscence, bleeding, ischemic bowel necrosis, pelvic infection (abscess), pelvic bleeding, bowel obstruction, stoma-related complications, and other complications occurring within 30 days. Anastomotic leakage is defined according to the criteria proposed by the International Study Group of Rectal Cancer (ISREC) in 2010, graded as A, B, or C, depending on severity and management.
11 secondary outcomes
Long-term Complications Rate
Time frame: postoperative 2 years
Total Surgery Time
Time frame: postoperative 1 years
LARS Score Questionnaire
Time frame: Every 6 months in the postoperative 3 years
Wexner Incontinence Score
Time frame: Every 6 months in the postoperative 3 years
International Prostate Symptom Score (IPSS) Questionnaire
Time frame: Every 6 months in the postoperative 3 years
The Fecal Incontinence Quality of Life Scale (FIQL).
Time frame: Every 6 months in the postoperative 3 years
International Index of Erectile Function (IIEF-5) Questionnaire
Time frame: Every 6 months in the postoperative 3 years
Female Sexual Function Index (FSFI) Questionnaire
Time frame: Every 6 months in the postoperative 3 years
EORTC QLQ-CR29 Questionnaire
Time frame: Every 6 months in the postoperative 3 years
3-year Disease-Free Survival (3-year DFS)
Time frame: postoperative 3 years
3-year Overall Survival (3-year OS)
Time frame: postoperative 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 35344150La 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.
- Background: PubMed 32492131Biondo 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.
- Background: PubMed 30690655Portale G, Popesc GO, Parotto M, Cavallin F. Delayed Colo-anal Anastomosis for Rectal Cancer: Pelvic Morbidity, Functional Results and Oncological Outcomes: A Systematic Review. World J Surg. 2019 May;43(5):1360-1369. doi: 10.1007/s00268-019-04918-y.
- Background: PubMed 19283735Remzi FH, El Gazzaz G, Kiran RP, Kirat HT, Fazio VW. Outcomes following Turnbull-Cutait abdominoperineal pull-through compared with coloanal anastomosis. Br J Surg. 2009 Apr;96(4):424-9. doi: 10.1002/bjs.6458.
- Background: PubMed 24344638Patsouras D, Yassin NA, Phillips RK. Clinical outcomes of colo-anal pull-through procedure for complex rectal conditions. Colorectal Dis. 2014 Apr;16(4):253-8. doi: 10.1111/codi.12532.
- Background: PubMed 13778709TURNBULL RB Jr, CUTHBERTSON A. Abdominorectal pull-through resection for cancer and for Hirschsprung's disease. Delayed posterior colorectal anastomosis. Cleve Clin Q. 1961 Apr;28:109-15. doi: 10.3949/ccjm.28.2.109. No abstract available.
- Background: PubMed 13882795CUTAIT DE, FIGLIOLINI FJ. A new method of colorectal anastomosis in abdominoperineal resection. Dis Colon Rectum. 1961 Sep-Oct;4:335-42. doi: 10.1007/BF02627230. No abstract available.
- Background: PubMed 26245947Man VC, Choi HK, Law WL, Foo DC. Morbidities after closure of ileostomy: analysis of risk factors. Int J Colorectal Dis. 2016 Jan;31(1):51-7. doi: 10.1007/s00384-015-2327-2. Epub 2015 Aug 6.
- Background: PubMed 31061647Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.
- Background: PubMed 22246846Martin ST, Heneghan HM, Winter DC. Systematic review of outcomes after intersphincteric resection for low rectal cancer. Br J Surg. 2012 May;99(5):603-12. doi: 10.1002/bjs.8677. Epub 2012 Jan 13.
- Background: PubMed 7953423Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg. 1994 Sep;81(9):1376-8. doi: 10.1002/bjs.1800810944.
- Derived from this study: PubMed 40405283Chen W, Ding J, Xiang J, Wang Y, Han J, Ye H, Wang D, Lin B, Lei J, Wu X, Di M, Fu Y, Yang G, Qin C, Chen A, Xu J, Liu W, Jiang C; STAR-TAR study group. Staged Turnbull-Cutait pull-through anastomosis comparing with direct anastomosis plus prophylactic ileostomy in the treatment of low rectal cancer after internal sphincter resection (STAR-TAR): study protocol for a randomized controlled trial. Trials. 2025 May 22;26(1):168. doi: 10.1186/s13063-025-08845-3.
- Individual participant dataSharing planned: Yes. http://www.medresman.org.cn/login.aspx http://www.medresman.org.cn/html/resman.pdf The Clinical Research Public Management Platform (Research Manager, ResMan) is an Electronic Data Capture (EDC) system that manages the clinical trial processes and records all relevant information, including baseline data of subjects such as demographic information, baseline data collected during enrollment, implementation details during the trial, and outcome data, encapsulated in the Case Record Form (CRF). All this information is recorded online via the internet and transmitted to a central database for management. Only researchers from the study group are allowed to access and operate the trial, while project managers, sponsors, or investors of funded projects have the right to view real-time data but cannot make any changes. Researchers decide whether to disclose research result data. Once data is entered and saved, any subsequent changes are automatically displayed and tracked.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Congqing Jiang, MD, PhD principal investigator
Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed transanal pull-through anastomosis and Direct Anastomosis Plus Prophylactic Ileostomy in people with Rectal Cancer and Rectal Carcinoma, run by Zhongnan Hospital at 1 site 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 10 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Overall Composite Postoperative Complication Rate (time frame: postoperative 30 days). 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 NCT06662643, which also lists 12 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 29 Oct 2024.