Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

China Medical University

Status: Enrolling

Conditions: Colorectal Carcinoma; Day Surgery

Treatments: Procedure: laparoscopic colorectal day surgery; Procedure: traditional laparoscopic colorectal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06637215

FirstHCMU_ambulatory_surgery

Details and patient eligibility

About

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。

Enrollment: 352 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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's research.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

laparoscopic colorectal day surgery

Experimental group

Description:

laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

Treatment:

Procedure: laparoscopic colorectal day surgery

traditional laparoscopic colorectal surgery

Active Comparator group

Description:

traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions

Treatment:

Procedure: traditional laparoscopic colorectal surgery