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

NCT06662643 | Active Not Recruiting

• 2 other identifiers: Zhongnan Hospital Wuhan2024054
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rectal Cancer; Rectal Carcinoma

Keywords

Low Rectal Cancer; Turnbull-Cutait; Pull-through; Internal Sphincter Resection

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative 30 days

Secondary Outcomes (11)

• Long-term Complications Rate

  postoperative 2 years

• Total Surgery Time

  postoperative 1 years

• LARS Score Questionnaire

  Every 6 months in the postoperative 3 years

• Wexner Incontinence Score

  Every 6 months in the postoperative 3 years

• International Prostate Symptom Score (IPSS) Questionnaire

  Every 6 months in the postoperative 3 years

Study Arms (2)

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.

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.

Procedure: Direct Anastomosis Plus Prophylactic Ileostomy

Interventions

Delayed transanal pull-through anastomosis PROCEDURE

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).

Staged Turnbull-Cutait Pull-through anastomosis group

Direct Anastomosis Plus Prophylactic Ileostomy PROCEDURE

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.

Direct anastomosis plus protective ileostomy 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:

• 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.
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead
• Ezhou Central Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Taihe Hospital: collaborator
• Hubei University of Medicine: collaborator
• Qilu Hospital of Shandong University: collaborator
• Beijing Chao Yang Hospital: collaborator
• Tianmen First People's Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• First People's Hospital of Xianyang: collaborator
• Central Hospital of Xiaogan: collaborator
• Yichang Central People's Hospital: collaborator
• Yichang Second People's Hospital: collaborator
• Rocket Force Special Medical Center of the People's Liberation Army: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430067, China

Location

Related Publications (12)

• 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.

  PMID: 35344150 BACKGROUND

• 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.

  PMID: 32492131 BACKGROUND

• Portale 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.

  PMID: 30690655 BACKGROUND

• Remzi 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.

  PMID: 19283735 BACKGROUND

• Patsouras 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.

  PMID: 24344638 BACKGROUND

• TURNBULL 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.

  PMID: 13778709 BACKGROUND

• CUTAIT 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.

  PMID: 13882795 BACKGROUND

• Man 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.

  PMID: 26245947 BACKGROUND

• Murken 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.

  PMID: 31061647 BACKGROUND

• Martin 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.

  PMID: 22246846 BACKGROUND

• Schiessel 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.

  PMID: 7953423 BACKGROUND

• Chen 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.

  PMID: 40405283 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Congqing Jiang, MD, PhD

  Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

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: Head of department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 29, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start Date: 6 months after primary results are published End Date: Data will remain available on the platform indefinitely, with no specified end date
• Access Criteria: Data will be made available to researchers who meet the following criteria: 1) possess a research plan approved by an Institutional Review Board (IRB); 2) have a clear scientific objective related to this clinical study. Researchers requesting access must submit an application, and upon approval, will receive controlled access. Data will be provided in anonymized form on a secure online data platform.

Locations

CN (1)