Clinical trial · Interventional
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial
NCT04527861CI-TRIAL-00061324CSILSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Laparoscopic Surgery | Procedure | — | UNRESOLVED |
| Single-incision Laparoscopic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single-incision Laparoscopic Surgery
- description
- Patients with colorectal cancer undergo single-incision laparoscopic surgery.
- interventionNames
- Procedure: Single-incision Laparoscopic Surgery
- type
- ACTIVE_COMPARATOR
- label
- Conventional Laparoscopic Surgery
- description
- Patients with colorectal cancer undergo conventional laparoscopic surgery（3\~5 ports）.
- interventionNames
- Procedure: Conventional Laparoscopic Surgery
Primary outcomes (1)
- measure
- 3-year disease free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years \< age ≤85 years * Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) * Pathological or highly suspected colorectal carcinoma * Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual * Tumor size of 5 cm or less * ECOG score is 0-1 * ASA score is Ⅰ-Ⅲ * Informed consent Exclusion Criteria: * Body mass index (BMI) \>35 kg/m2 * The lower border of the tumor is located distal to the peritoneal reflection * Familial adenomatous polyposis (FAP) * Inflammatory bowel disease (IBD) * Multiple malignant colorectal tumors * Pregnant woman or lactating woman * Severe mental disease * Previous gastrointestinal surgery (except appendectomy ） * Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * Requirement of simultaneous surgery for other disease * Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years
References
Publications (3)
- BACKGROUNDMaggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836. PMID 30303873
- BACKGROUNDLee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882. PMID 32209897
- DERIVEDSong Z, Liu K, Zhang T, Wang B, Shi Y, Jiang Y, Wang C, Chen X, Ji X, Zhao R. Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial. BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9. PMID 35799145