Clinical Research on the Treatment Model of Ambulatory Su... | NCT06637215

NCT06637215

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic colorectal day surgery	Experimental	laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions	Procedure: laparoscopic colorectal day surgery
traditional laparoscopic colorectal surgery	Active Comparator	traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions	Procedure: traditional laparoscopic colorectal surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic colorectal day surgery	Procedure	laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

Outcomes Module

Measure	Description	Time Frame
Recurrence-free survival (DFS)		From enrollment to the end of treatment at 36 months
Overall survival (OS)		From enrollment to the end of treatment at 36 months

Secondary Outcomes

Measure	Description	Time Frame
BIood system disorders	Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe but not immediately life-threatening; Grade 4: Life-threatening; Grade 5: Death. Anemia: Grade 1: HemogIobin (Hgb) \

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients voluntarily joined this study and signed an informed consent form；
Age: 18-75 years old；
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)；
Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
Preoperative staging: cT1-3NanyM0;
Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
Does not require conventional anticoagulant therapy or antiplatelet therapy；
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:

Elderly patients with multiple basic diseases；
Moderate to severe anemia；
Severe hypoproteinemia；
Diabetes that is not well controlled；
Contraindications to laparoscopic surgery；
Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
Patients with distant metastases；
Patients who are unwilling to sign informed consent or follow-up according to the research plan；
People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
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's research.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site