Clinical trial NCT04527861: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Rectal Cancer
Keywords: single-incision laparoscopic surgery
conventional laparoscopic surgery
colorectal cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Dongfang Hospital Affiliated to Tongji University
name: Fudan University
name: Changhai Hospital
name: Shengjing Hospital
name: RenJi Hospital
name: Liaoning Cancer Hospital & Institute
name: Zhejiang Provincial People's Hospital
name: Shandong Provincial Hospital
name: The General Hospital of Western Theater Command
name: Shanghai Jiao Tong University School of Medicine
First posted: 2020-08-27
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months after surgery
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Incision length
timeFrame: intraoperative
measure: Total incision length
timeFrame: intraoperative
measure: Conversion rate
timeFrame: intraoperative
measure: Length of stay
timeFrame: 1-14 days after surgery
measure: Postoperative recovery course
timeFrame: 1-14 days after surgery
measure: Early morbidity rate
timeFrame: 30 days after surgery
measure: Pain score
timeFrame: 1-3 days after surgery
measure: Tumor size
timeFrame: 14 days after surgery
measure: Incisal margin
timeFrame: 14 days after surgery
measure: Lymph node detection
timeFrame: 14 days after surgery
measure: Cosmetic effect
timeFrame: 1 month, 6 months and 1 year after surgery
measure: The quality of life-Core
timeFrame: 1 month, 6 months and 1 year after surgery
measure: The quality of life-Colorectal
timeFrame: 1 month, 6 months and 1 year after surgery
measure: 5-year overall survival rate
timeFrame: 60 months after surgery
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
state: Gansu
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Tumor Hospital & Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Chendu
country: China
facility: The General Hospital of Western Theater Command
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Cancer Center
city: Shanghai
country: China
facility: Dongfang Hospital Affiliated to Tongji University
city: Shanghai
country: China
facility: RenJi Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
name: Ren Zhao, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongfang Hospital Affiliated to Tongji University
name: Chun Song, MD
role: STUDY_DIRECTOR
affiliation: Shanghai Cancer Center
name: Ye Xu, MD
role: STUDY_DIRECTOR
affiliation: Changhai Hospital
name: Liqiang Hao, MD
role: STUDY_DIRECTOR
affiliation: Shengjing Hospital
name: Hong Zhang, MD
role: STUDY_DIRECTOR
affiliation: RenJi Hospital
name: Hong Zhou, MD
role: STUDY_DIRECTOR
affiliation: Liaoning Cancer Hospital & Institute
name: Qingtong Zhang, MD
role: STUDY_DIRECTOR
affiliation: Zhejiang Provincial People's Hospital
name: Shiliang Tu, MD
role: STUDY_DIRECTOR
affiliation: Shandong Provincial Hospital
name: Xiaoqiao Zhang, MD
role: STUDY_DIRECTOR
affiliation: The General Hospital of Western Theater Command
name: Lin Zhang, MD
role: STUDY_DIRECTOR
affiliation: The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
name: Feng Gao, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.