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

• ClinicalTrials.gov Identifier: NCT04527861
• Recruitment Status: Recruiting
• First Posted: August 27, 2020
• Last Update Posted: October 10, 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
• Information provided by (Responsible Party): Zhao Ren, Ruijin Hospital

Tracking Information

• First Submitted Date: August 19, 2020
• First Posted Date: August 27, 2020
• Last Update Posted Date: October 10, 2022
• Actual Study Start Date: April 8, 2021
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2020)

3-year disease free survival rate [ Time Frame: 36 months after surgery ]

3-year disease free survival rate

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 21, 2020)

• Operative time [ Time Frame: intraoperative ]
  Operative time（minutes）
• Intraoperative blood loss [ Time Frame: intraoperative ]
  Estimated blood loss（milliliters，ml）
• Incision length [ Time Frame: intraoperative ]
  Incision length（centimeters，cm）
• Total incision length [ Time Frame: intraoperative ]
  The sum of all incision lengths（centimeters，cm）
• Conversion rate [ Time Frame: intraoperative ]
  The proportion of converted to laparotomy and added trocars（%）
• Length of stay [ Time Frame: 1-14 days after surgery ]
  The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
• Postoperative recovery course [ Time Frame: 1-14 days after surgery ]
  Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）
• Early morbidity rate [ Time Frame: 30 days after surgery ]
  morbidity rate 30 days after surgery
• 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
• Tumor size [ Time Frame: 14 days after surgery ]
  The diameter of tumors（centimeters，cm）
• Incisal margin [ Time Frame: 14 days after surgery ]
  Length of proximal and distal margin （centimeters，cm）
• Lymph node detection [ Time Frame: 14 days after surgery ]
  Lymph nodes harvested（numbers）
• 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''
• 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)
• 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)
• 5-year overall survival rate [ Time Frame: 60 months after surgery ]
  5-year overall survival rate

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Colorectal Cancer
• Colon Cancer
• Rectal Cancer

Intervention

• 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
• 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

Study Arms

• Experimental: Single-incision Laparoscopic Surgery
  Patients with colorectal cancer undergo single-incision laparoscopic surgery.
  Intervention: Procedure: Single-incision Laparoscopic Surgery
• Active Comparator: Conventional Laparoscopic Surgery
  Patients with colorectal cancer undergo conventional laparoscopic surgery（3~5 ports）.
  Intervention: Procedure: Conventional Laparoscopic Surgery

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2020): 710
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2029
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ren Zhao, MD, PHD; +8618917762018; zhaorensurgeon@aliyun.com

Contact: Kun Liu, MD; +8618121263082; lookiere@126.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04527861
• Other Study ID Numbers: CSILS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zhao Ren, Ruijin Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Ruijin Hospital
• Original Study Sponsor: Same as current

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

Investigators

• 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

• PRS Account: Ruijin Hospital
• Verification Date: October 2022