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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer
• Intervention / Treatment: Procedure: Single-incision Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

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 Type: Interventional
• Enrollment (Anticipated): 710
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Renji Hospital
    • Contact: Hong Zhou, MD; Email: renjizhouhong@163.com
  • Shanghai, China, 200032
    • Recruiting
    • Shanghai Cancer Center
    • Contact: Ye Xu, MD; Email: xu_shirley021@163.com
  • Shanghai, China, 200120
    • Recruiting
    • Dongfang Hospital Affiliated to Tongji University
    • Contact: Chun Song, MD; Email: chunsong163@163.com
  • Shanghai, China, 200438
    • Recruiting
    • Changhai Hospital
    • Contact: Liqiang Hao, MD; Email: hao_liqiang@139.com
  • Shanghai, China, 201801
    • Recruiting
    • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Recruiting
      • The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
      • Contact: Feng Gao, MD; Email: gaof678@sohu.com
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital
      • Contact: Hong Zhang, MD; Email: haojiubujian1203@sina.com
    • Shenyang, Liaoning, China, 110801
      • Recruiting
      • Liaoning Tumor Hospital & Institute
      • Contact: Qingtong Zhang, MD; Email: 2690960111@qq.com
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Xiaoqiao Zhang, MD; Email: xqz@vip.163.com
  • Sichuan
    • Chendu, Sichuan, China, 610083
      • Recruiting
      • The General Hospital of Western Theater Command
      • Contact: Lin Zhang, MD; Email: flysky8026@aliyun.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial people's hospital
      • Contact: Shiliang Tu, MD; Email: yuanhang1981@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: CLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate	3-year disease free survival rate	36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time（minutes）	intraoperative
Intraoperative blood loss	Estimated blood loss（milliliters，ml）	intraoperative
Incision length	Incision length（centimeters，cm）	intraoperative
Lymph node detection	Lymph nodes harvested（numbers）	14 days after surgery
Incisal margin	Length of proximal and distal margin （centimeters，cm）	14 days after surgery
Tumor size	The diameter of tumors（centimeters，cm）	14 days after surgery
5-year overall survival rate	5-year overall survival rate	60 months after surgery
Total incision length	The sum of all incision lengths（centimeters，cm）	intraoperative
Conversion rate	The proportion of converted to laparotomy and added trocars（%）	intraoperative
Length of stay	The postoperative day when patients complied with the predefined discharge criteria（days after surgery）	1-14 days after surgery
Postoperative recovery course	Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）	1-14 days after surgery
Early morbidity rate	morbidity rate 30 days after surgery	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	1-3 days after surgery
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''	1 month, 6 months and 1 year after surgery
The quality of life-Core	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	1 month, 6 months and 1 year after surgery
The quality of life-Colorectal	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29)	1 month, 6 months and 1 year after surgery

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Changhai Hospital; Fudan University; RenJi Hospital; Shengjing Hospital; Shandong Provincial Hospital; Shanghai Jiao Tong University School of Medicine; The General Hospital of Western Theater Command; Zhejiang Provincial People's Hospital; Dongfang Hospital Affiliated to Tongji University; Liaoning Cancer Hospital & Institute
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2021
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2029

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; single-incision laparoscopic surgery; conventional laparoscopic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CSILS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No