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

Korábbi kezelés

• Previous colorectal or anorectal surgeries or diseases.
• Tumor invasion into the external sphincter, levator ani, or adjacent organs requiring combined organ resection.
• Participation in other clinical trials within the 4 weeks prior to enrollment.

Más betegség

• History of malignant colorectal tumors.
• Patients requiring emergency surgery due to intestinal obstruction, perforation, or bleeding.
• History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP).
• Recent diagnosis of other malignancies.
• Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction or serious underlying disease precluding surgery.
• History of severe mental illness.
• Uncontrolled preoperative infection.

Laborértékek

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

Egyéb

• Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).
• ASA classification ≥ IV or ECOG performance status ≥ 2.
• Pregnant or breastfeeding women.

• 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).