Learning Curve of SILS in CRC | NCT07736131

NCT07736131

Overview

NCT ID: NCT07736131
Lead Sponsor: Ruijin HospitalOTHER
Official Title: The Influence of the Learning Curve on the Short-term and Long-term Efficacy of Single-incision Laparoscopic Rectal and Sigmoid Colon Surgery: An Observational Cohort Study
Brief 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.
Conditions: Rectal Cancer
Colon Cancer
Single Port Laparoscopy

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.