Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer
Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer
1 other identifier
interventional
352
1 country
1
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。
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 9, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
ExpectedNovember 27, 2024
April 1, 2024
2.4 years
September 9, 2024
November 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (7)
BIood system disorders
From enrollment to the end of treatment at 1 week
Pain evaluation
From one hour after surgery to the end of treatment at 48 hours
Cardiac disorders
From enrollment to the end of treatment at 1 week
CoIonic fistuIa
From enrollment to the end of treatment at 1 week
AbdominaI infection
From enrollment to the end of treatment at 1 week
- +2 more secondary outcomes
Study Arms (2)
laparoscopic colorectal day surgery
EXPERIMENTALlaparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
traditional laparoscopic colorectal surgery
ACTIVE COMPARATORtraditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Interventions
laparoscopic colorectal day surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director of surgical Oncology
Study Record Dates
First Submitted
September 9, 2024
First Posted
October 15, 2024
Study Start
November 1, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2029
Last Updated
November 27, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share