Comparing single-incision and conventional laparoscopic surgery for colorectal cancer outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) versus conventional laparoscopic surgery (CLS) for patients with colorectal cancer. The aim is to assess whether SILS can provide better cosmetic results and reduced postoperative pain while maintaining oncologic safety. Given the limited existing data on long-term outcomes, this large-scale, randomized controlled trial seeks to clarify the effectiveness and best indications for SILS in colorectal cancer treatment. Participants will be closely monitored for oncologic outcomes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• The 940th Hospital of Joint Logistic Support Force of Chinese of PLA
  Lanzhou, Gansu, China Recruiting
• Shengjing Hospital
  Shenyang, Liaoning, China Recruiting
• Liaoning Tumor Hospital & Institute
  Shenyang, Liaoning, China Recruiting
• Shandong Provincial Hospital
  Jinan, Shandong, China Recruiting
• The General Hospital of Western Theater Command
  Chengdu, Sichuan, China Recruiting
• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ren Zhao, MD, PHD — Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
• Study coordinator: Ren Zhao, MD, PHD
• Email: zhaorensurgeon@aliyun.com
• Phone: +8618917762018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.