Clinical trial NCT06637215: Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer
Official title: Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Day Surgery
Keywords: Colorectal cancer
Day surgery
Laparoscope
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily joined this study and signed an informed consent form；
2. Age: 18-75 years old；
3. The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I\~III)；
4. Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
5. Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
6. Preoperative staging: cT1-3NanyM0;
7. Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
8. There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
9. Does not require conventional anticoagulant therapy or antiplatelet therapy；
10. Relatives or co-residents should be able to provide 24 hours of full escort within at least 72 hours after the operation, the place of residence is not more than a 30-minute drive from the hospital, and they can understand and follow the phased treatment plan of diet, analgesic drugs, etc. after the operation.

Exclusion Criteria:

1. Elderly patients with multiple basic diseases；
2. Moderate to severe anemia；
3. Severe hypoproteinemia；
4. Diabetes that is not well controlled；
5. Contraindications to laparoscopic surgery；
6. Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
7. Patients with distant metastases；
8. Patients who are unwilling to sign informed consent or follow-up according to the research plan；
9. People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
10. Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
11. After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
12. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the patient\&#39;s research.

Primary outcomes:
measure: Recurrence-free survival (DFS)
timeFrame: From enrollment to the end of treatment at 36 months
measure: Overall survival (OS)
timeFrame: From enrollment to the end of treatment at 36 months
Secondary outcomes:
measure: BIood system disorders
timeFrame: From enrollment to the end of treatment at 1 week
measure: Pain evaluation
timeFrame: From one hour after surgery to the end of treatment at 48 hours
measure: Cardiac disorders
timeFrame: From enrollment to the end of treatment at 1 week
measure: CoIonic fistuIa
timeFrame: From enrollment to the end of treatment at 1 week
measure: AbdominaI infection
timeFrame: From enrollment to the end of treatment at 1 week
measure: AnorectaI infection
timeFrame: From enrollment to the end of treatment at 1 week
measure: Fever
timeFrame: From enrollment to the end of treatment at 1 week
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
References: