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Patients with early cervical cancer are usually treated with radical hysterectomy + pelvic lymph-node dissection. The study randomizes patients in 2 arms. The control arm is the classical surgical treatment including identification of the sentinel nodes, full pelvic lymph-node dissection and radical hysterectomy.
The experimental arm is only sentinel node identification + radical hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy A | Experimental | Only identification of sentinel nodes (without pelvic lymph-node dissection) |
|
| Strategy B | Other | Identification of sentinel nodes + full pelvic lymph-node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| identification of sentinel nodes + full pelvic lymph-node dissection | Procedure | identification of sentinel nodes + full pelvic lymph-node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with complications observed in the 2 arms during the per and post-operative period up to 6 months | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Score of the questionnaire of quality of life at 30 days, 3 months and 6 months after surgery | 30 days, 3 months and 6 months after surgery | |
| the costs of both studied strategies | At the surgery until 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Gynécologie, Hôpital Femme Mère Enfant | Bron | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25727652 | Result | Bats AS, Frati A, Mathevet P, Orliaguet I, Querleu D, Zerdoud S, Leblanc E, Gauthier H, Uzan C, Deandreis D, Darai E, Kerrou K, Marret H, Lenain E, Froissart M, Lecuru F. Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort. Gynecol Oncol. 2015 May;137(2):264-9. doi: 10.1016/j.ygyno.2015.02.018. Epub 2015 Feb 26. | |
| 33773275 |
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| only identification of sentinel nodes (without pelvic lymph-node dissection) | Procedure | only identification of sentinel nodes (without pelvic lymph-node dissection) |
|
| the detection rate of the sentinel node technique in the 2 arms | Day 1 |
| the false negative rate in the control arm | Day 1 |
| the sites of recurrence for each strategy | Day 1 |
| Number of patients without 3 years-recurrence for each strategy | 3 years after surgery |
| Number of patient treated by radio chemotherapy because of the presence of micrometastases in the sentinel node | 30 days, 3 months and 6 months after surgery |
| Result |
| Mathevet P, Lecuru F, Uzan C, Boutitie F, Magaud L, Guyon F, Querleu D, Fourchotte V, Baron M, Bats AS; Senticol 2 group. Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2). Eur J Cancer. 2021 May;148:307-315. doi: 10.1016/j.ejca.2021.02.009. Epub 2021 Mar 24. |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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