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

NCT ID: NCT06662643

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2029-12-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Staged Turnbull-Cutait Pull-through anastomosis group

Participants in this group will undergo staged Turnbull-Cutait pull-through anastomosis for the treatment of low rectal cancer after internal sphincter resection.

Group Type: EXPERIMENTAL

Delayed transanal pull-through anastomosis

Intervention Type: 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).

Direct anastomosis plus protective ileostomy group

Participants in this group will receive direct anastomosis combined with a prophylactic ileostomy.

Group Type: ACTIVE_COMPARATOR

Direct Anastomosis Plus Prophylactic Ileostomy

Intervention Type: 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.

Interventions

Delayed transanal pull-through anastomosis

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).

Intervention Type: PROCEDURE

Direct Anastomosis Plus Prophylactic Ileostomy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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).

3. Both male and female patients aged 18-75.

4. Non-recurrent rectal cancer.

5. No concurrent multiple primary colorectal cancers.

6. Initial staging or post-neoadjuvant therapy stage: T3 above the levator ani, T1-2 below.

7. Liver or lung oligometastases deemed resectable after evaluation by a multidisciplinary team (MDT).

8. Patients may or may not have received neoadjuvant chemoradiotherapy.

9. Patients and families must understand and be willing to participate in this study, providing written informed consent.

10. Good anal function (Wexner incontinence score ≤ 5).

Exclusion Criteria

1. History of malignant colorectal tumors.

2. Previous colorectal or anorectal surgeries or diseases.

3. Patients requiring emergency surgery due to intestinal obstruction, perforation, or bleeding.

4. Tumor invasion into the external sphincter, levator ani, or adjacent organs requiring combined organ resection.

5. Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).

6. History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP).

7. Recent diagnosis of other malignancies.

8. Participation in other clinical trials within the 4 weeks prior to enrollment.

9. ASA classification ≥ IV or ECOG performance status ≥ 2.

10. Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction or serious underlying disease precluding surgery.

11. History of severe mental illness.

12. Pregnant or breastfeeding women.

13. Uncontrolled preoperative infection.

14. Other clinical or laboratory findings making the patient unsuitable for the study, as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ezhou Central Hospital

UNKNOWN

Sponsor Role: collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role: collaborator

Taihe Hospital

OTHER

Sponsor Role: collaborator

Hubei University of Medicine

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Tianmen First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Xianyang

OTHER

Sponsor Role: collaborator

Central Hospital of Xiaogan

OTHER

Sponsor Role: collaborator

Yichang Central People's Hospital

OTHER

Sponsor Role: collaborator

Yichang Second People's Hospital

OTHER

Sponsor Role: collaborator

Rocket Force Special Medical Center of the People's Liberation Army

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Congqing Jiang

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Congqing Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 32492131 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30690655 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 24344638 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

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Other Identifiers

2024054

Identifier Type: OTHER

Identifier Source: secondary_id

Zhongnan Hospital Wuhan

Identifier Type: -

Identifier Source: org_study_id