Colorectal cancer
Conditions
Interventions
Experimental Group: Exteriorized bowel resection at 7-15 days:Exteriorized bowel resection at 7-15 days
Control Group: Exteriorized bowel resection at 15-28 days.:Exteriorized bowel resection at 15-28 days.
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.Histopathological confirmation of high- or intermediate-grade adenocarcinoma, or preoperative colonoscopy suggesting malignant transformation of a villous adenoma; 3.Non-recurrent rectal cancer; 4.No synchronous multiple colorectal cancers; 5.Preoperative MRI measurement showing the tumor <=5 cm from the anal verge, Bordeaux type I~III; 6.Preoperative tumor staging: Stage I (cT1~2N0M0); For Stage II~III (cT3~4N0~2M0) patients, neoadjuvant chemotherapy is required, with post-treatment downstaging to: For tumors above the levator hiatus: <=ycT3N0-2M0; For tumors below the levator hiatus: <=ycT2NxM0 (i.e., depth of invasion not exceeding the internal sphincter); 7.Preoperative American Society of Anesthesiologists (ASA) physical status classification I~III; 8.No preoperative local complications (including intestinal obstruction, perforation, abdominal abscess formation, etc.); 9.Good preoperative anal control function (preoperative Wexner score <=5); 10.Preoperative comprehensive assessment (nutritional risk, comorbidities, etc.) confirming suitability for modified Bacon surgery; 11.Patients and their families must understand and be willing to participate in the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with tumor invasion of the external sphincter, levator ani muscle, or adjacent organs requiring combined organ resection; 2.Patients with poorly differentiated or undifferentiated carcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma; 3.Patients with familial adenomatous polyposis, Lynch syndrome-associated rectal cancer, or active inflammatory bowel disease; 4.Patients with concurrent other malignancies; 5.Patients with distant metastasis of the tumor; 6.Patients with a history of previous colorectal or anorectal surgery or disease; 7.Patients with poor preoperative anal function (preoperative Wexner score >= 6); 8.Patients with preoperative digital examination indicating anal stenosis that cannot be relieved; 9.Patients with preoperative American Society of Anesthesiologists (ASA) physical status classification IV or V; 10.Patients with severe hepatic, renal, cardiac, pulmonary, or coagulation dysfunction, or severe underlying diseases that preclude tolerance for surgery; 11.Patients who are pregnant and/or lactating; 12.Patients with abnormal cognitive status, reading/writing difficulties, or a history of severe mental illness; 13.Patients with uncontrolled preoperative infections; 14.Patients currently participating in other clinical trials or who have participated in other clinical trials within 4 weeks prior to enrollment; 15.Patients who have undergone preoperative radiotherapy; 16.Patients with other clinical or laboratory findings deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-Day Postoperative Complications: Aggregate Incidence and Severity Following Second-Stage Surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival Rate;Low Anterior Resection Syndrome Score;Global Health Status Score (EORTC QLQ-C30);Operative Time;VAS Pain Score on Postoperative Days 1-5;Blood Loss;Postoperative Hospital Stay Length After Second-Stage Surgery;Incidence of Long-Term Complications; | — |
Countries
China
Contacts
Public ContactHu Junhong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed