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Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer (CSILS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527861
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : October 10, 2022
Sponsor:
Collaborators:
Dongfang Hospital Affiliated to Tongji University
Fudan University
Changhai Hospital
Shengjing Hospital
RenJi Hospital
Liaoning Cancer Hospital & Institute
Zhejiang Provincial People's Hospital
Shandong Provincial Hospital
The General Hospital of Western Theater Command
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Zhao Ren, Ruijin Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colon Cancer Rectal Cancer Procedure: Single-incision Laparoscopic Surgery Procedure: Conventional Laparoscopic Surgery Not Applicable

Detailed Description:
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2029
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-incision Laparoscopic Surgery
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
 Procedure: 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.
Other Name: SILS
Active Comparator: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）.
 Procedure: Conventional Laparoscopic Surgery
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Other Name: CLS


Outcome Measures
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Primary Outcome Measures :
  1. 3-year disease free survival rate [ Time Frame: 36 months after surgery ]
    3-year disease free survival rate


Secondary Outcome Measures :
  1. Operative time [ Time Frame: intraoperative ]
    Operative time（minutes）

  2. Intraoperative blood loss [ Time Frame: intraoperative ]
    Estimated blood loss（milliliters，ml）

  3. Incision length [ Time Frame: intraoperative ]
    Incision length（centimeters，cm）

  4. Total incision length [ Time Frame: intraoperative ]
    The sum of all incision lengths（centimeters，cm）

  5. Conversion rate [ Time Frame: intraoperative ]
    The proportion of converted to laparotomy and added trocars（%）

  6. Length of stay [ Time Frame: 1-14 days after surgery ]
    The postoperative day when patients complied with the predefined discharge criteria（days after surgery）

  7. Postoperative recovery course [ Time Frame: 1-14 days after surgery ]
    Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）

  8. Early morbidity rate [ Time Frame: 30 days after surgery ]
    morbidity rate 30 days after surgery

  9. Pain score [ Time Frame: 1-3 days after surgery ]
    Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3

  10. Tumor size [ Time Frame: 14 days after surgery ]
    The diameter of tumors（centimeters，cm）

  11. Incisal margin [ Time Frame: 14 days after surgery ]
    Length of proximal and distal margin （centimeters，cm）

  12. Lymph node detection [ Time Frame: 14 days after surgery ]
    Lymph nodes harvested（numbers）

  13. Cosmetic effect [ Time Frame: 1 month, 6 months and 1 year after surgery ]
    Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied''

  14. The quality of life-Core [ Time Frame: 1 month, 6 months and 1 year after surgery ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  15. The quality of life-Colorectal [ Time Frame: 1 month, 6 months and 1 year after surgery ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)

  16. 5-year overall survival rate [ Time Frame: 60 months after surgery ]
    5-year overall survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527861


Contacts
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Contact: Ren Zhao, MD, PHD +8618917762018 zhaorensurgeon@aliyun.com
Contact: Kun Liu, MD +8618121263082 lookiere@126.com

Locations
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China, Gansu
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA Recruiting
Lanzhou, Gansu, China, 730050
Contact: Feng Gao, MD       gaof678@sohu.com   
China, Liaoning
Shengjing Hospital Recruiting
Shenyang, Liaoning, China, 110004
Contact: Hong Zhang, MD       haojiubujian1203@sina.com   
Liaoning Tumor Hospital & Institute Recruiting
Shenyang, Liaoning, China, 110801
Contact: Qingtong Zhang, MD       2690960111@qq.com   
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Xiaoqiao Zhang, MD       xqz@vip.163.com   
China, Sichuan
The General Hospital of Western Theater Command Recruiting
Chendu, Sichuan, China, 610083
Contact: Lin Zhang, MD       flysky8026@aliyun.com   
China, Zhejiang
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Shiliang Tu, MD       yuanhang1981@126.com   
China
Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Ye Xu, MD       xu_shirley021@163.com   
Dongfang Hospital Affiliated to Tongji University Recruiting
Shanghai, China, 200120
Contact: Chun Song, MD       chunsong163@163.com   
RenJi Hospital Recruiting
Shanghai, China, 200127
Contact: Hong Zhou, MD       renjizhouhong@163.com   
Changhai Hospital Recruiting
Shanghai, China, 200438
Contact: Liqiang Hao, MD       hao_liqiang@139.com   
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 201801
Contact: Kun Liu, MD    +8618121263082    lookiere@126.com   
Sponsors and Collaborators
Ruijin Hospital
Dongfang Hospital Affiliated to Tongji University
Fudan University
Changhai Hospital
Shengjing Hospital
RenJi Hospital
Liaoning Cancer Hospital & Institute
Zhejiang Provincial People's Hospital
Shandong Provincial Hospital
The General Hospital of Western Theater Command
Shanghai Jiao Tong University School of Medicine
Investigators
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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 Tumor 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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhao Ren, Chief Physicion, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04527861    
Other Study ID Numbers: CSILS
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Ren, Ruijin Hospital:
single-incision laparoscopic surgery
conventional laparoscopic surgery
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases