Comparing single-incision and conventional laparoscopic surgery for colorectal cancer outcomes
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
NA · Ruijin Hospital · NCT04527861
This study is testing if a newer type of surgery with one small cut can help people with colorectal cancer have less pain and better healing compared to the usual surgery with multiple cuts.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 710 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 11 sites (Lanzhou, Gansu and 10 other locations) |
| Trial ID | NCT04527861 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with localized colorectal carcinoma and specific staging criteria.
Not a fit: Patients with a BMI over 35, inflammatory bowel disease, or those requiring simultaneous surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for colorectal cancer patients, enhancing recovery and cosmetic outcomes.
How similar studies have performed: Previous studies have shown SILS to be feasible and safe in the short term, but long-term outcomes remain inconclusive, making this approach novel in its comprehensive evaluation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lanzhou, Gansu and 10 other locations
- 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)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer, Colon Cancer, Rectal Cancer, single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer