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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

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