Low rectal cancer
Conditions
Interventions
Intervention Group:Modified Bacon Procedure
Control Group:Immediate Coloanal Anastomosis with Protective Ileostomy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years; 2. Histopathologically confirmed high-grade or intermediate-grade adenocarcinoma, or preoperative colonoscopy suggesting malignant transformation of a villous adenoma; 3. The lower edge of the tumor is located =5 cm from the anal verge, and the primary tumor diameter is <5 cm; 4. Non-recurrent rectal cancer; 5. Absence of synchronous multiple colorectal cancers; 6. Patients may or may not have received neoadjuvant chemoradiotherapy; 7. Preoperative tumor staging is Stage I (cT1~2N0M0); For Stage II~III (cT3~4N0~2M0) patients, after neoadjuvant therapy, tumors above the levator hiatus must be downstaged to = ycT3N0-2M0, and tumors at or below the levator hiatus must be downstaged to = ycT2NxM0 (i.e., invasion depth does not exceed the internal sphincter); 8. Preoperative American Society of Anesthesiologists (ASA) physical status classification of I~III; 9. Absence of preoperative local complications (including intestinal obstruction, intestinal perforation, abdominal abscess formation, etc.); 10. Good preoperative anal control function (preoperative Wexner score = 5); 11. Preoperative assessment indicates the patient is physically capable of undergoing radical ultra-low anterior resection and is suitable for either immediate coloanal anastomosis with ileostomy or the modified Bacon procedure (comprehensive assessment including nutritional risk and comorbidities); 12. The patient and their family must understand and be willing to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients requiring emergency surgery due to intestinal obstruction, perforation, or hemorrhage; 2. Patients with tumor invasion of the external sphincter, levator ani muscle, or adjacent organs requiring combined organ resection; 3. Patients with pathological types of poorly differentiated or undifferentiated carcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma; 4. Patients with familial adenomatous polyposis, Lynch syndrome-associated rectal cancer, or active inflammatory bowel disease; 5. Patients with other concurrent malignancies; 6. Patients with distant metastasis; 7. Patients with a history of previous colorectal or anorectal surgery or disease; 8. Patients with poor preoperative anal function (preoperative Wexner score = 6); 9. Patients with preoperative digital rectal examination indicating anal stenosis that cannot be relieved; 10. Patients with preoperative ASA classification of IV or V; 11. Patients with severe hepatic, renal, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases unable to tolerate surgery; 12. Pregnant and/or lactating patients; 13. Patients with abnormal cognitive status, illiteracy/difficulty reading and writing, or a history of severe mental illness; 14. Patients with uncontrolled preoperative infection; 15. Patients currently participating in other clinical trials; 16. Patients with any other clinical or laboratory findings deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 30-day Overall Complication Rate;Postoperative 30-day Complication Profile and Severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Blood Loss;Operative Time;Distant Metastasis Rate;Local Recurrence Rate;Overall Survival Rate;Postoperative Hospital Stay;Fecal Incontinence Score;Long-term Complication Rate;Postoperative Pain Score;Quality of Life Core Questionnaire Score;Time to First Liquid Intake;Time to First Normal Diet;Time to First Flatus;Low Anterior Resection Syndrome Score;Time to First Ambulation;Disease-free Survival Rate; | — |
Countries
China
Contacts
Public ContactJunhong Hu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed