Exploring the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
This study is testing if a specific type of surgery for colorectal cancer called laparoscopic intracorporeal anastomosis is safe and effective compared to another method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05911152 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and feasibility of laparoscopic intracorporeal anastomosis in patients undergoing surgery for colorectal cancer. It will analyze clinical data from approximately 2,000 patients who had laparoscopic surgery between April 2016 and April 2020, comparing outcomes between those who underwent intracorporeal anastomosis and those who had extracorporeal anastomosis. The study will evaluate primary endpoints such as 3-year disease-free survival and overall survival, along with secondary endpoints including complication rates and postoperative recovery metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia who are eligible for laparoscopic surgery.
Not a fit: Patients with contraindications to laparoscopic surgery or those requiring emergency interventions due to complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a safer and more effective surgical technique for colorectal cancer patients.
How similar studies have performed: While similar approaches have been explored, this study focuses on a specific technique in a large cohort, making it a significant contribution to existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients voluntarily enrolled in this study and signed an informed consent form; 2. Age: 18-75 years; 3. Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia; 4. Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis; 5. Preoperative staging as cT1-3NanyM0; 6. Underwent laparoscopic surgery. Exclusion Criteria: 1. Contraindications to laparoscopic surgery; 2. Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding; 3. Patients with distant metastasis; 4. Patients with multiple primary colorectal cancers; 5. Patients with a history of malignancy; 6. Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.
Where this trial is running
Beijing, Beijing
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Mingguang Zhang, Dr.
- Email: zmgslimshady@163.com
- Phone: +8613261967603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.