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NCT06662643

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

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-05-08

Completion Date

2029-12-30

Last Updated

2024-10-29

Healthy Volunteers

Conditions

Rectal Cancer Rectal Carcinoma

Interventions

PROCEDURE

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).

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.

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.

Locations (1)

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

Wuhan, Hubei, China