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NCT05495048

Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy

Recruiting now NA Last updated 26 February 2024
What this trial tests

NA trial testing NOSES VIIIA in Colon Cancer in 356 participants. Currently enrolling.

Timeline
1 July 2023
Primary endpoint
31 December 2028
31 December 2028

Quick facts

Lead sponsorShanghai Minimally Invasive Surgery Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment356
Start date1 July 2023
Primary completion31 December 2028
Estimated completion31 December 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Minimally Invasive Surgery Center — full company profile →

Who can join

Adults 18 to 75, female only, with Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy.
    Yu M, Cai Z, Zhou H, Fingerhut A, et al · · 2023 · cited 4× · PMID 38108112 · DOI 10.2217/fon-2023-0769

Verify or expand the search:

Other recruiting trials for Colon Cancer

Currently open trials in the same condition.

Other Shanghai Minimally Invasive Surgery Center trials

Trials by the same sponsor.

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Data sources for this page

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