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Trial Title:
Clinical Research on the Treatment Model of Laparoscopic Colorectal Day Surgery
NCT ID:
NCT06637215
Condition:
Colorectal Carcinoma
Day Surgery
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Day surgery
Laparoscope
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic colorectal day surgery
Description:
laparoscopic colorectal day surgery in patients with colorectal tumor who are generally
in good health and have sufficient organ functions
Arm group label:
laparoscopic colorectal day surgery
Intervention type:
Procedure
Intervention name:
traditional laparoscopic colorectal surgery
Description:
traditional laparoscopic colorectal surgery in patients with colorectal tumor who are
generally in good health and have sufficient organ functions
Arm group label:
traditional laparoscopic colorectal surgery
Summary:
To investigate the postoperative complication incidence and long-term efficacy between
laparoscopic colorectal day surgery and traditional laparoscopic colorectal surgery in
patients with colorectal tumor who are generally in good health and have sufficient organ
functions。
Criteria for 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's research.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kai Li, MD
Phone:
8613998245233
Email:
cmu_likai@163.com
Start date:
November 1, 2023
Completion date:
March 31, 2029
Lead sponsor:
Agency:
First Hospital of China Medical University
Agency class:
Other
Source:
First Hospital of China Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637215
