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| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | the group of LRH |
|
| 2 | Active Comparator | the group of ARH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Laparoscopic or Robotic Radical Hysterectomy | Other | Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of PFS at 5 years | The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated. | 5 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of OS at 5 years | Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate. | 5 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of continuous outcomes | Compare these between groups(The continuous outcomes include operative duration, anesthesia time, blood loss during operation, postoperative pain score and postoperative hospital stay.) | 1 years from surgery |
| Analysis of binary outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wu, PHD | Contact | (021)33189900-6529 | wuxin_fc@fudan.edu.cn | |
| Jiang Hua, PHD | Contact | (021)33189900-6529 | jianghua@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wu, PHD | The Obstetrics and Gynecology Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35395868 | Derived | Wu X, Qiu L, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. Trials. 2022 Apr 8;23(1):269. doi: 10.1186/s13063-022-06245-5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2020 | Oct 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| RenJi Hospital |
| OTHER |
| Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences | UNKNOWN |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
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|
| Total Abdominal Radical Hysterectomy | Other | Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina. |
|
Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event.) |
| 5 years from surgery |
| Safety analysis | Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups. | 5 years from surgery |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |