NCT04201717Active, not recruiting
Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer
A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)
Source: ClinicalTrials.gov · Last updated 7 May 2025
Brief summary (registry, in English)
This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 350 (actual)
- First submitted
- 12 Dec 2019
- Start date
- 27 Jan 2021
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Jilin University
- Diseases
- Colorectal cancer
- NCT number
- NCT04201717
What you commit to
- Study type: Interventional
- Participants enrolled: 350
- From 27 Jan 2021 to the primary completion date, 3 Jul 2024
- 12 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
- Patients who need to undergo combined organ resection or robot-assisted colectomy.
- Patients who are receiving preoperative neoadjuvant therapy.
- Patients who need combined organ resection as determined by intraoperative exploration.
Other illness
- Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
- Patients with severe psychiatric illness.
- Patients who have a history of taking hormonal drugs.
- Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
- Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
Lab values
- Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal);
- Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
- Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.
- Exit criteria
Other
- ASA grade ≥ IV and/or ECOG performance status score \> 2.
- Pregnant or lactating women.
- Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
- Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.
Who the study is looking for
- age between 18 and 80 years;
- histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
- clinical stage T1-4a, N0-2, and M0;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- suitable for laparoscopic colectomy;
- no previous systemic chemotherapy or radiotherapy;
- willing to provide written informed consent and comply with the research procedures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese People's Liberation Army General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Daping Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.