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

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527861
• Other study ID #: CSILS
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: April 2029

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: Ren Zhao, MD, PHD
• Phone: +8618917762018
• Email: zhaorensurgeon[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 710
• Est. completion date: April 2029
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ?-?

• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• 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.
• Conventional Laparoscopic Surgery
In this group,the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Locations

Country	Name	City	State
China	The General Hospital of Western Theater Command	Chendu	Sichuan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The 940th Hospital of Joint Logistic Support Force of Chinese of PLA	Lanzhou	Gansu
China	Changhai Hospital	Shanghai
China	Dongfang Hospital Affiliated to Tongji University	Shanghai
China	RenJi Hospital	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Cancer Center	Shanghai
China	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (11)

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

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	3-year disease free survival rate	36 months after surgery
Secondary	Operative time	Operative time(minutes)	intraoperative
Secondary	Intraoperative blood loss	Estimated blood loss(milliliters,ml)	intraoperative
Secondary	Incision length	Incision length(centimeters,cm)	intraoperative
Secondary	Total incision length	The sum of all incision lengths(centimeters,cm)	intraoperative
Secondary	Conversion rate	The proportion of converted to laparotomy and added trocars(%)	intraoperative
Secondary	Length of stay	The postoperative day when patients complied with the predefined discharge criteria(days after surgery)	1-14 days after surgery
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and semi-liquid diet (hours after surgery)	1-14 days after surgery
Secondary	Early morbidity rate	morbidity rate 30 days after surgery	30 days after surgery
Secondary	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
Secondary	Tumor size	The diameter of tumors(centimeters,cm)	14 days after surgery
Secondary	Incisal margin	Length of proximal and distal margin (centimeters,cm)	14 days after surgery
Secondary	Lymph node detection	Lymph nodes harvested(numbers)	14 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	5-year overall survival rate	5-year overall survival rate	60 months after surgery