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

Primary Purpose

Colorectal Cancer, Colon Cancer, Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single-incision Laparoscopic Surgery
Conventional Laparoscopic Surgery
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 940th Hospital of Joint Logistic Support Force of Chinese of PLARecruiting
  • Shengjing HospitalRecruiting
  • Liaoning Tumor Hospital & InstituteRecruiting
  • Shandong Provincial HospitalRecruiting
  • The General Hospital of Western Theater CommandRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Shanghai Cancer CenterRecruiting
  • Dongfang Hospital Affiliated to Tongji UniversityRecruiting
  • RenJi HospitalRecruiting
  • Changhai HospitalRecruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-incision Laparoscopic Surgery

Conventional Laparoscopic Surgery

Arm Description

Patients with colorectal cancer undergo single-incision laparoscopic surgery.

Patients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）.

Outcomes

Primary Outcome Measures

3-year disease free survival rate
3-year disease free survival rate

Secondary Outcome Measures

Operative time
Operative time（minutes）
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Incision length
Incision length（centimeters，cm）
Total incision length
The sum of all incision lengths（centimeters，cm）
Conversion rate
The proportion of converted to laparotomy and added trocars（%）
Length of stay
The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）
Early morbidity rate
morbidity rate 30 days after surgery
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3
Tumor size
The diameter of tumors（centimeters，cm）
Incisal margin
Length of proximal and distal margin （centimeters，cm）
Lymph node detection
Lymph nodes harvested（numbers）
Cosmetic effect
Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied''
The quality of life-Core
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The quality of life-Colorectal
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)
5-year overall survival rate
5-year overall survival rate

Full Information

First Posted
August 19, 2020
Last Updated
October 7, 2022
Sponsor
Ruijin Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT04527861
Brief Title
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Acronym
CSILS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer, Rectal Cancer
Keywords
single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
710 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-incision Laparoscopic Surgery
Arm Type
Experimental
Arm Description
Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Arm Title
Conventional Laparoscopic Surgery
Arm Type
Active Comparator
Arm Description
Patients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）.
Intervention Type
Procedure
Intervention Name(s)
Single-incision Laparoscopic Surgery
Other Intervention Name(s)
SILS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Laparoscopic Surgery
Other Intervention Name(s)
CLS
Intervention Description
In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months after surgery
Secondary Outcome Measure Information:
Title
Operative time
Description
Operative time（minutes）
Time Frame
intraoperative
Title
Intraoperative blood loss
Description
Estimated blood loss（milliliters，ml）
Time Frame
intraoperative
Title
Incision length
Description
Incision length（centimeters，cm）
Time Frame
intraoperative
Title
Total incision length
Description
The sum of all incision lengths（centimeters，cm）
Time Frame
intraoperative
Title
Conversion rate
Description
The proportion of converted to laparotomy and added trocars（%）
Time Frame
intraoperative
Title
Length of stay
Description
The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
Time Frame
1-14 days after surgery
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）
Time Frame
1-14 days after surgery
Title
Early morbidity rate
Description
morbidity rate 30 days after surgery
Time Frame
30 days after surgery
Title
Pain score
Description
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3
Time Frame
1-3 days after surgery
Title
Tumor size
Description
The diameter of tumors（centimeters，cm）
Time Frame
14 days after surgery
Title
Incisal margin
Description
Length of proximal and distal margin （centimeters，cm）
Time Frame
14 days after surgery
Title
Lymph node detection
Description
Lymph nodes harvested（numbers）
Time Frame
14 days after surgery
Title
Cosmetic effect
Description
Assessed using a "Beauty Questionnaire" evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied''
Time Frame
1 month, 6 months and 1 year after surgery
Title
The quality of life-Core
Description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame
1 month, 6 months and 1 year after surgery
Title
The quality of life-Colorectal
Description
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)
Time Frame
1 month, 6 months and 1 year after surgery
Title
5-year overall survival rate
Description
5-year overall survival rate
Time Frame
60 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ren Zhao, MD, PHD
Phone
+8618917762018
Email
zhaorensurgeon@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Liu, MD
Phone
+8618121263082
Email
lookiere@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ren Zhao, MD, PHD
Organizational Affiliation
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chun Song, MD
Organizational Affiliation
Dongfang Hospital Affiliated to Tongji University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ye Xu, MD
Organizational Affiliation
Shanghai Cancer Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liqiang Hao, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hong Zhou, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qingtong Zhang, MD
Organizational Affiliation
Liaoning Tumor Hospital & Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shiliang Tu, MD
Organizational Affiliation
Zhejiang Provincial People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaoqiao Zhang, MD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lin Zhang, MD
Organizational Affiliation
The General Hospital of Western Theater Command
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Feng Gao, MD
Organizational Affiliation
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
Official's Role
Study Director
Facility Information:
Facility Name
The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Gao, MD
Email
gaof678@sohu.com
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD
Email
haojiubujian1203@sina.com
Facility Name
Liaoning Tumor Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingtong Zhang, MD
Email
2690960111@qq.com
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoqiao Zhang, MD
Email
xqz@vip.163.com
Facility Name
The General Hospital of Western Theater Command
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Zhang, MD
Email
flysky8026@aliyun.com
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiliang Tu, MD
Email
yuanhang1981@126.com
Facility Name
Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Xu, MD
Email
xu_shirley021@163.com
Facility Name
Dongfang Hospital Affiliated to Tongji University
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Song, MD
Email
chunsong163@163.com
Facility Name
RenJi Hospital
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhou, MD
Email
renjizhouhong@163.com
Facility Name
Changhai Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqiang Hao, MD
Email
hao_liqiang@139.com
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
201801
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Liu, MD
Phone
+8618121263082
Email
lookiere@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30303873
Citation
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.
Results Reference
background
PubMed Identifier
32209897
Citation
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.
Results Reference
background
PubMed Identifier
35799145
Citation
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.
Results Reference
derived

Learn more about this trial

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

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