NCT05495048Recruiting
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
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)
Source: ClinicalTrials.gov · Last updated 26 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 356 (estimated)
- First submitted
- 9 Aug 2022
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Diseases
- Colorectal cancer
- NCT number
- NCT05495048
What you commit to
- Study type: Interventional
- Planned participants: 356
- From 1 Jul 2023 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- contraindications for laparoscopic surgery;
- has received preoperative chemoradiotherapy;
Other illness
- emergency surgery due to acute intestinal obstruction, perforation or bleeding;
- multiple colorectal cancer;
- with a history of other malignant tumors;
Other
- distant metastasis;
- unwilling to sign the informed consent or receive follow-up according to the study protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.