NCT06637215Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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。
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- First Hospital of China Medical University
- Diseases
- Colorectal cancer
- NCT number
- NCT06637215
What you commit to
- Study type: Interventional
- Planned participants: 352
- From 1 Nov 2023 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to laparoscopic surgery;
- 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.
Other illness
- Elderly patients with multiple basic diseases;
- Diabetes that is not well controlled;
- Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding;
- People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
Other
- Moderate to severe anemia;
- Severe hypoproteinemia;
- Patients with distant metastases;
- Patients who are unwilling to sign informed consent or follow-up according to the research plan;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.