Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
NCT ID: NCT04527861
Last Updated: 2022-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
710 participants
INTERVENTIONAL
2021-04-08
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-incision Laparoscopic Surgery
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Single-incision Laparoscopic Surgery
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.
Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（3\~5 ports）.
Conventional Laparoscopic Surgery
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Interventions
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Single-incision Laparoscopic Surgery
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.
Conventional Laparoscopic Surgery
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Dongfang Hospital Affiliated to Tongji University
OTHER
Fudan University
OTHER
Changhai Hospital
OTHER
Shengjing Hospital
OTHER
RenJi Hospital
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Zhejiang Provincial People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
The General Hospital of Western Theater Command
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Zhao Ren
Chief Physicion
Principal Investigators
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Ren Zhao, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
Chun Song, MD
Role: STUDY_DIRECTOR
Dongfang Hospital Affiliated to Tongji University
Ye Xu, MD
Role: STUDY_DIRECTOR
Shanghai Cancer Center
Liqiang Hao, MD
Role: STUDY_DIRECTOR
Changhai Hospital
Hong Zhang, MD
Role: STUDY_DIRECTOR
Shengjing Hospital
Hong Zhou, MD
Role: STUDY_DIRECTOR
RenJi Hospital
Qingtong Zhang, MD
Role: STUDY_DIRECTOR
Liaoning Cancer Hospital & Institute
Shiliang Tu, MD
Role: STUDY_DIRECTOR
Zhejiang Provincial People's Hospital
Xiaoqiao Zhang, MD
Role: STUDY_DIRECTOR
Shandong Provincial Hospital
Lin Zhang, MD
Role: STUDY_DIRECTOR
The General Hospital of Western Theater Command
Feng Gao, MD
Role: STUDY_DIRECTOR
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Locations
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The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Lanzhou, Gansu, China
Shengjing Hospital
Shenyang, Liaoning, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
The General Hospital of Western Theater Command
Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Shanghai Cancer Center
Shanghai, , China
Dongfang Hospital Affiliated to Tongji University
Shanghai, , China
RenJi Hospital
Shanghai, , China
Changhai Hospital
Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Lee 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.
Song 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.
Other Identifiers
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CSILS
Identifier Type: -
Identifier Source: org_study_id
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