Comparing two surgical methods for right colon cancer treatment
Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)
This study is testing whether a new surgical method for treating right colon cancer is as effective as the standard laparoscopic surgery for women aged 18-75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shanghai Minimally Invasive Surgery Center Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05495048 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transvaginal natural orifice specimen extraction (NOSES VIIIA) compared to conventional laparoscopic surgery with mini-laparotomy for patients with right colon cancer. It is a multicenter, open-label, parallel, non-inferiority, randomized controlled trial enrolling 356 female patients aged 18-75 with specific cancer characteristics. Participants will be randomly assigned to either the experimental or control group, and various perioperative indicators, pathological results, quality of life, and cosmetic outcomes will be assessed. A three-year follow-up will provide insights into the long-term oncological outcomes of the NOSES approach.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-75 with pathologically confirmed right colon adenocarcinoma and specific tumor characteristics.
Not a fit: Patients with contraindications for laparoscopic surgery or those with advanced disease stages or multiple cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive surgical option with improved recovery and cosmetic outcomes for patients with right colon cancer.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in minimally invasive techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * volunteer to participate and the informed consent signed; * 18-75 years; * female who have given birth; * pathologically confirmed adenocarcinoma/high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy; * preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm; * preoperative staging cT1-3NanyM0 * body mass index \<30 kg/m2; * willing to undergo laparoscopic right hemicolectomy Exclusion Criteria: * contraindications for laparoscopic surgery; * emergency surgery due to acute intestinal obstruction, perforation or bleeding; * distant metastasis; * multiple colorectal cancer; * has received preoperative chemoradiotherapy; * with a history of other malignant tumors; * unwilling to sign the informed consent or receive follow-up according to the study protocol.
Where this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (Recruiting)
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.