Treatment model for colorectal cancer using ambulatory surgery

Open, Parallel, Randomized Controlled, Non-inferior, Phase III Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

This study tests whether a less invasive day surgery for colorectal cancer can lead to fewer complications and better long-term results for generally healthy patients compared to traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 352 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Hospital of China Medical University (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06637215 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the incidence of postoperative complications and long-term efficacy of ambulatory surgery compared to traditional laparoscopic surgery for colorectal cancer. It focuses on patients who are generally healthy and have sufficient organ function, specifically targeting those with adenocarcinoma or high-level intraepithelial neoplasia. The study involves laparoscopic colorectal day surgery and aims to determine the benefits of a less invasive approach. Participants will undergo thorough preoperative assessments to ensure eligibility.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-75 with colorectal tumors that are ≤5.0 cm in diameter and no serious comorbidities.

Not a fit: Patients with advanced colorectal cancer or significant comorbidities that may complicate surgery are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced complications and improved recovery times for patients undergoing colorectal cancer surgery.

How similar studies have performed: Other studies have shown promising results with laparoscopic approaches in colorectal surgery, suggesting potential for success in this trial.

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.

Where this trial is running

Shenyang, Liaoning

• First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Kai Li

Conditions Colorectal Carcinoma; Day Surgery; Colorectal cancer; Day surgery; Laparoscope