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

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.

• BACKGROUNDLa 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
• BACKGROUNDBiondo 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
• BACKGROUNDPortale 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
• BACKGROUNDRemzi 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
• BACKGROUNDPatsouras 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
• BACKGROUNDTURNBULL 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
• BACKGROUNDCUTAIT 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.