Comparing Tubeless NOSES and Traditional Surgery for Rectosigmoid Cancers
Official title: A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT04037956 · Data updated 2026-11-12
This study is testing if a new type of surgery called Tubeless NOSES is as safe and effective as traditional surgery for people with rectosigmoid cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 458 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2019 |
| Main results expected | July 31, 2025 |
| Study ends | July 31, 2027 |
| Registry record updated | March 31, 2022 |
| Trial ID | NCT04037956 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically confirmed rectosigmoid cancers, clinical stage T1-3 N0-2 M0, and tumor size no more than 3 cm.
✕Probably not a fit
Patients with severe organ dysfunction, previous colorectal malignancies, or those requiring emergency surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the short-term and long-term outcomes of Tubeless Natural Orifice Specimen Extraction Surgery (NOSES) versus traditional laparoscopic radical resection in patients with rectosigmoid cancers. It is a randomized, single-center, open-label, non-inferiority trial involving approximately 458 subjects. The aim is to assess the safety, efficacy, and potential benefits of the Tubeless NOSES approach compared to conventional surgical methods.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option with improved recovery outcomes for patients with rectosigmoid cancers.
How similar studies have gone: Other studies have shown promising results with similar minimally invasive approaches, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed Rectosigmoid Cancers 2. Clinical stage at T 1-3 N0-2 M0 3. Tumors on peritoneal reflection，Tumor size is no more than 3 cm 4. Eastern Cooperative Oncology Group (ECOG) scale is 0-2 5. American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ 6. BMI ≤ 30 kg/m2 7. Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing. Exclusion Criteria: 1. Heart, lung, liver or renal or any organ function that are intolerance for surgery 2. History of treated colorectal malignant disease 3. Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery 4. Subjects with previous malignancies 5. History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP) 6. Treatment with any other clinical trial within 28 days prior to randomization 7. History of severe mentally disease 8. pregnant or lactating women 9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
Where it's running
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The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Yanxin Luo, MD，PHD
- Email: luoyx25@mail.sysu.edu.cn
- Phone: 86-13826190263
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing a new surgical tool for colorectal cancer surgery to see if it is safe and works well compared to robotic surgery techniques for patients with rectal and rectosigmoid junction cancers.
-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.