Learning Curve of SILS in CRC

NCT07736131 | Completed

• 1 other identifier: RJ-SILS-CRC
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of cases for the learning curve

  week 4

Study Arms (1)

single-incision laparoscopic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent single-incision radical resection of rectal or sigmoid colon tumors in the General Surgery Department of Ruijin Hospital from December 2013 to June 2021

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Related Publications (1)

• Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.

  PMID: 34760706 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: December 1, 2013
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share