Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
CSILS
1 other identifier
interventional
710
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Apr 2021
Longer than P75 for not_applicable colorectal-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
ExpectedOctober 10, 2022
October 1, 2022
3 years
August 19, 2020
October 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year disease free survival rate
3-year disease free survival rate
36 months after surgery
Secondary Outcomes (16)
Operative time
intraoperative
Intraoperative blood loss
intraoperative
Incision length
intraoperative
Total incision length
intraoperative
Conversion rate
intraoperative
- +11 more secondary outcomes
Study Arms (2)
Single-incision Laparoscopic Surgery
EXPERIMENTALPatients with colorectal cancer undergo single-incision laparoscopic surgery.
Conventional Laparoscopic Surgery
ACTIVE COMPARATORPatients with colorectal cancer undergo conventional laparoscopic surgery（3\~5 ports）.
Interventions
In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- Dongfang Hospital Affiliated to Tongji Universitycollaborator
- Fudan Universitycollaborator
- Changhai Hospitalcollaborator
- Shengjing Hospitalcollaborator
- RenJi Hospitalcollaborator
- Liaoning Cancer Hospital & Institutecollaborator
- Zhejiang Provincial People's Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- The General Hospital of Western Theater Commandcollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
Study Sites (11)
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Lanzhou, Gansu, 730050, China
Shengjing Hospital
Shenyang, Liaoning, 110004, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, 110801, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, 610083, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Shanghai Cancer Center
Shanghai, 200032, China
Dongfang Hospital Affiliated to Tongji University
Shanghai, 200120, China
RenJi Hospital
Shanghai, 200127, China
Changhai Hospital
Shanghai, 200438, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 201801, China
Related Publications (3)
Maggiori 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: 30303873BACKGROUNDLee 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: 32209897BACKGROUNDSong 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: 35799145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ren Zhao, MD, PHD
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
- STUDY DIRECTOR
Chun Song, MD
Dongfang Hospital Affiliated to Tongji University
- STUDY DIRECTOR
Ye Xu, MD
Shanghai Cancer Center
- STUDY DIRECTOR
Liqiang Hao, MD
Changhai Hospital
- STUDY DIRECTOR
Hong Zhang, MD
Shengjing Hospital
- STUDY DIRECTOR
Hong Zhou, MD
RenJi Hospital
- STUDY DIRECTOR
Qingtong Zhang, MD
Liaoning Cancer Hospital & Institute
- STUDY DIRECTOR
Shiliang Tu, MD
Zhejiang Provincial People's Hospital
- STUDY DIRECTOR
Xiaoqiao Zhang, MD
Shandong Provincial Hospital
- STUDY DIRECTOR
Lin Zhang, MD
The General Hospital of Western Theater Command
- STUDY DIRECTOR
Feng Gao, MD
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physicion
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 27, 2020
Study Start
April 8, 2021
Primary Completion
April 1, 2024
Study Completion (Estimated)
April 1, 2029
Last Updated
October 10, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share