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CompletedNCT07736131SILSUpdated Jul 30, 2026

Learning Curve of SILS in CRC

An observational study in Rectal Cancer, Colon Cancer and Single Port Laparoscopy, sponsored by Ruijin Hospital. Completed. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
280
Sex
All
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Study 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.

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Conditions studied

  • Rectal Cancer
  • Colon Cancer
  • Single Port Laparoscopy
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In context

Rectal Neoplasms

1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 280 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
280 participants (actual)
Patient registry
No

Groups and cohorts

  • single-incision laparoscopic surgery
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What researchers measure

Primary outcomes

  1. Number of cases for the learning curve

    Time frame: week 4

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 34760706 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07736131
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Jul 30, 2026
Start date
Dec 1, 2013
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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