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

NCT04527861 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Not applicable

Started

2021-04-08

Last updated

2022-10-10

Condition(s) studied

Colorectal CancerColon CancerRectal Cancer

Investigational drug(s) / intervention(s)

Single-incision Laparoscopic SurgeryConventional Laparoscopic Surgery

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

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

Primary outcome measure(s)

3-year disease free survival rate — 36 months after surgery
3-year disease free survival rate

Trial sites (11)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04527861 on ClinicalTrials.gov ↗ ← All trials in China