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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOSES VIIIA | Experimental | totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction |
|
| laparoscopic surgery with mini-laparotomy | Active Comparator | laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOSES VIIIA | Procedure | totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival rate | disease-free survival rate | 3 years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38108112 | Derived | Yu M, Cai Z, Zhou H, Fingerhut A, He Z, Xue P, Song H, Yang X, Cheng X, Zhang S, Xu X, Zhong H, Abuduaini N, Liu J, Wang X, Feng B. Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy. Future Oncol. 2023 Dec;19(40):2641-2650. doi: 10.2217/fon-2023-0769. Epub 2023 Dec 18. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| laparoscopic surgery with mini-laparotomy | Procedure | laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |