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Trial Title:
Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy
NCT ID:
NCT05495048
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
NOSES VIIIA
Description:
totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen
extraction
Arm group label:
NOSES VIIIA
Intervention type:
Procedure
Intervention name:
laparoscopic surgery with mini-laparotomy
Description:
laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy
Arm group label:
laparoscopic surgery with mini-laparotomy
Summary:
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenghao Cai
Phone:
+862164458887
Email:
c3z2h1@alumni.sjtu.edu.cn
Start date:
July 1, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Shanghai Minimally Invasive Surgery Center
Agency class:
Other
Source:
Shanghai Minimally Invasive Surgery Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495048