Actively Recruiting
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Led by Shanghai Minimally Invasive Surgery Center · Updated on 2024-02-26
356
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.
CONDITIONS
Official Title
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign informed consent
- Age between 18 and 75 years
- Female who have given birth
- Pathologically confirmed adenocarcinoma or high-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy
- Tumor diameter no more than 5.0 cm on preoperative CT or MRI
- Preoperative staging cT1-3NanyM0
- Body mass index less than 30 kg/m2
- Willing to undergo laparoscopic right hemicolectomy
You will not qualify if you...
- Contraindications for laparoscopic surgery
- Emergency surgery due to acute intestinal obstruction, perforation, or bleeding
- Presence of distant metastasis
- Multiple colorectal cancers
- Previous preoperative chemoradiotherapy
- History of other malignant tumors
- Unwilling to sign informed consent or follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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