NCT04527861Recruiting
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
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
Source: ClinicalTrials.gov · Last updated 10 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 710 (estimated)
- First submitted
- 19 Aug 2020
- Start date
- 8 Apr 2021
- Primary completion date
- Apr 2024
- Lead sponsor
- Ruijin Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04527861
What you commit to
- Study type: Interventional
- Planned participants: 710
- From 8 Apr 2021 to the primary completion date, Apr 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal surgery (except appendectomy ）
Other illness
- Inflammatory bowel disease (IBD)
- Multiple malignant colorectal tumors
- Severe mental disease
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Age
- Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years
Other
- Body mass index (BMI) \>35 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Familial adenomatous polyposis (FAP)
- Pregnant woman or lactating woman
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The General Hospital of Western Theater Command Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The 940th Hospital of Joint Logistic Support Force of Chinese of PLA Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Dongfang Hospital Affiliated to Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shengjing Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Liaoning Tumor Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.