Low rectal cancer
Conditions
Interventions
Group B:Multi-needle fixation of external intestinal tube
Group A:One-shot method for external fixation of intestinal tubes.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-75 years old; 2. Pathology confirmed as high-grade or intermediate-grade adenocarcinoma, or preoperative colonoscopy suggested as a villous adenoma malignant transformation; 3. Tumour located within <=5 cm of the anal verge, primary tumour diameter <5 cm; 4. Non-recurrent rectal cancer; 5. The patient may or may not have had neoadjuvant chemotherapy and radiotherapy. 6. Preoperative MRI shows the tumor is <=5cm from the anal verge, Bordeaux classification type I~III; 7. Preoperative tumor staging of Stage I (cT1~2N0M0); patients with Stage II~III (cT3~4N0~2M0) require neoadjuvant therapy, after which tumors located above the levator ani hiatus should be downstaged to <=ycT3N0-2M0, and tumors located below the levator ani hiatus should be downstaged to <=ycT2NxM0 (i.e., the invasion depth does not exceed the internal sphincter). 8. Preoperative American Society of Anesthesiologists (ASA) classification I–III; 9. No local complications before surgery (including intestinal obstruction, intestinal perforation, abdominal abscess formation, etc.); 10. Good preoperative anal sphincter control (preoperative Wexner score <=5); 11. Preoperative evaluation of the patient's physical condition indicates they can undergo radical ultra-low anterior resection of the rectum, and a one-stage anastomosis combined with ileostomy or modified Bacon procedure is feasible (comprehensive assessment of nutritional risk, comorbidities, etc.). 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 who need emergency surgery for intestinal obstruction, perforation, or bleeding. 2. Tumors that invade the external sphincter, levator ani, or adjacent organs, and require combined organ resection; 3. Pathological types of low differentiation or undifferentiated carcinoma, mucinous adenocarcinoma, and signet ring cell carcinoma; 4. Familial adenomatous polyposis, Lynch syndrome-associated colorectal cancer, and patients with active inflammatory bowel; 5. Patients with other malignant tumors were combined; 6. Patients with distant metastasis of tumors; 7. History of previous colorectal or anorectal surgery or disease; 8. Patients with poor preoperative anal function (preoperative Wexner score =6); 9. Patients with anal stenosis that cannot be relieved on preoperative digital examination; 10. Patients classified as ASA IV and V by the American Society of Anesthesiologists (ASA) preoperatively; 11. Patients with severe liver, kidney, heart, lung, or coagulation dysfunction, or those with serious underlying diseases who cannot tolerate surgery; 12. Patients who are pregnant and/or breastfeeding; 13. Patients with cognitive impairment, reading and writing difficulties, or a history of severe mental illness; 14. Patients whose preoperative infection is not controlled; 15. Patients who are currently participating in other clinical trials or who have participated in other clinical trials within the past 4 weeks before enrollment; 16. Patients with clinical or laboratory findings that other researchers judge to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative anal function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative quality of life;Duration of external intestinal tube fixation;Postoperative hospitalization indicators (such as time to first flatus, time to first ambulation, time to first liquid diet, time to first regular diet, VAS pain scores from postoperative days 1 to 5,;Duration of surgery;Composition of postoperative complications at 30 days and the incidence and severity grading of each; | — |
Countries
China
Contacts
Public ContactHu Junhong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed