Learning Curve of SILS in CRC (NCT07736131) | Clinical Trial Compass
CompletedNot Applicable
Learning Curve of SILS in CRC
280 participantsStarted 2013-12-01
Plain-language summary
Based on the data analysis of the General Surgery Department (Northern Department) of Ruijin Hospital from December 2013 to June 2021, we conducted a retrospective cohort study. Multivariate risk-adjusted cumulative sum analysis (RA-CUSUM) was used to evaluate the learning curve of single-incision laparoscopic surgery performed by the same surgical team based on short-term surgical outcomes. Subsequently, by comparing the 5-year follow-up results of patients who received treatment at different stages of the learning curve, analyses of overall survival and progression-free survival were conducted.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Patients with indications for single-port laparoscopic surgery; 2) A single tumor was found during colonoscopy; 3) Preoperative biopsy confirmed by pathology as cancer or high-grade intraepithelial neoplasia; 4) The lesion is located in the lower segment of the sigmoid colon (20 cm to 25 cm from the proximal rectum), the junction of the sigmoid colon (16 cm to 20 cm from the proximal rectum), or the upper segment of the rectum (12 cm to 16 cm from the proximal rectum) \[31-33\]; 5) Intestinal anastomosis in vivo was performed through a tubular stapler.
Exclusion Criteria:
* 1\) Has undergone colorectal resection; 2) Preoperative CT assessment shows that the tumor stage is stage IV (as defined in the 8th edition of the American Joint Committee on Cancer (AJCC) "Cancer Staging Manual"); 3) Intestinal anastomosis was performed in vitro or not; 4) Received neoadjuvant therapy; 5) ASA classification is III-IV (in accordance with the ASA standards of the American Society of Anesthesiologists); 6) Life expectancy is less than one year; 7) There is a history of cancers other than thyroid cancer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.