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

Not Applicable

Active, not recruiting

• Conditions: Rectal Cancer; Rectal Carcinoma

• Registration Number: NCT06662643
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study Start: 2024-05-08
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-05-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-Day Overall Composite Postoperative Complication Rate	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.

Secondary Outcome Measures

Name	Time	Method
Long-term Complications Rate	postoperative 2 years	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).
Total Surgery Time	postoperative 1 years	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).
LARS Score Questionnaire	Every 6 months in the postoperative 3 years	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.
Wexner Incontinence Score	Every 6 months in the postoperative 3 years	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.
International Prostate Symptom Score (IPSS) Questionnaire	Every 6 months in the postoperative 3 years	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.
The Fecal Incontinence Quality of Life Scale (FIQL).	Every 6 months in the postoperative 3 years	Quality of Life
International Index of Erectile Function (IIEF-5) Questionnaire	Every 6 months in the postoperative 3 years	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.
Female Sexual Function Index (FSFI) Questionnaire	Every 6 months in the postoperative 3 years	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.
EORTC QLQ-CR29 Questionnaire	Every 6 months in the postoperative 3 years	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.
3-year Disease-Free Survival (3-year DFS)	postoperative 3 years	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.
3-year Overall Survival (3-year OS)	postoperative 3 years	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.

Trial Locations

Locations (1)

Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China