Comparing Tubeless NOSES and Traditional Surgery for Rectosigmoid Cancers
A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04037956 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe organ dysfunction, previous colorectal malignancies, or those requiring emergency surgery may not benefit from this study.
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 performed: Other studies have shown promising results with similar minimally invasive approaches, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
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.