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Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total hysterectomy with a uterine manipulator | Experimental | Total hysterectomy with bilateral salpingo-oophorectomy performed with the use of a uterine manipulator during surgery. |
|
| Total hysterectomy without a uterine manipulator | No Intervention | Total hysterectomy with bilateral salpingo-oophorectomy performed without the use of a uterine manipulator during surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine manipulator use | Device | The uterine manipulator will be inserted into the uterus to assist in the procedure of total hysterectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Any recurrence or death related to endometrial cancer (EC) or treatment | Each follow-up visit, up to 4 years from the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cause-specific survival | Any death related to endometrial cancer (EC) or treatment | Each follow-up visit, up to 4 years from the day of surgery |
| Overall survival | Any death for any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Uccella, MD, PhD | Contact | 0039 045 812 2720 | stefano.uccella@univr.it | |
| Simone Garzon, MD | Contact | 0039 045 812 2720 | simone.garzon@univr.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Uccella, MD, PhD | AOUI Verona - University of Verona | Principal Investigator |
| Simone Garzon, MD | AOUI Verona - University of Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle | Recruiting | Cuneo | Italy | 12100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33397713 | Background | Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18. | |
| 25967852 |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Multicenter, parallel arms, open-label, randomized controlled trial.
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| Each follow-up visit, up to 4 years from the day of surgery |
| Site-specific recurrence-free survival | Any recurrence per site of first recurrence | Each follow-up visit, up to 4 years from the day of surgery |
| Operative time | Time between first incision and skin closure | Day of surgery |
| Intraoperative blood loss | Total blood aspirate during the surgical procedure | Day of surgery |
| 30-day post-surgical morbidity | Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification | 30 days after surgery |
| Lymphovascular space invasion | Presence of lymphovascular space invasion at definitive pathology | Day of surgery |
| Peritoneal cytology | Presence of positive peritoneal cytology at definitive pathology | Day of surgery |
| Quality of life indexes | The Functional Assessment of Cancer Therapy - General (FACT-G) - A 27-item questionnaire designed to measure four domains of Health-Related Quality of Life in cancer patients: Physical, social, emotional, and functional well-being. Score range 0-108. The higher the score, the better the Quality of Life. | Each follow-up visit, up to 4 years from the day of surgery |
| Pier Carlo Zorzato, MD |
| AOUI Verona - University of Verona |
| Principal Investigator |
| UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova | Recruiting | Reggio Emilia | Italy |
|
| AOUI Verona - University of Verona - Department of Obstetrics and Gynecology | Recruiting | Verona | 37125 | Italy |
|
| Background |
| van den Haak L, Alleblas C, Nieboer TE, Rhemrev JP, Jansen FW. Efficacy and safety of uterine manipulators in laparoscopic surgery: a review. Arch Gynecol Obstet. 2015 Nov;292(5):1003-11. doi: 10.1007/s00404-015-3727-9. Epub 2015 May 13. |
| 33207238 | Background | Uccella S, Cianci S, Gueli Alletti S. Uterine manipulator in endometrial cancer: we are still far from the answer. Am J Obstet Gynecol. 2021 Mar;224(3):332. doi: 10.1016/j.ajog.2020.09.049. Epub 2020 Nov 15. No abstract available. |
| 28147240 | Background | Uccella S, Bonzini M, Malzoni M, Fanfani F, Palomba S, Aletti G, Corrado G, Ceccaroni M, Seracchioli R, Shakir F, Ferrero A, Berretta R, Tinelli R, Vizza E, Roviglione G, Casarella L, Volpi E, Cicinelli E, Scambia G, Ghezzi F. The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy. Am J Obstet Gynecol. 2017 Jun;216(6):592.e1-592.e11. doi: 10.1016/j.ajog.2017.01.027. Epub 2017 Jan 29. |
| 32693096 | Background | Padilla-Iserte P, Lago V, Tauste C, Diaz-Feijoo B, Gil-Moreno A, Oliver R, Coronado P, Martin-Salamanca MB, Pantoja-Garrido M, Marcos-Sanmartin J, Gilabert-Estelles J, Lorenzo C, Cazorla E, Roldan-Rivas F, Rodriguez-Hernandez JR, Sanchez L, Muruzabal JC, Hervas D, Domingo S; Spanish Society of Gynecology and Obstetrics Spanish Investigational Network Gynecologic Oncology Group. Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. Am J Obstet Gynecol. 2021 Jan;224(1):65.e1-65.e11. doi: 10.1016/j.ajog.2020.07.025. Epub 2020 Jul 18. |
| 39266205 | Derived | Uccella S, Puppo A, Ghezzi F, Zorzato PC, Ceccaroni M, Mandato VD, Berretta R, Camanni M, Seracchioli R, Perrone AM, Chiantera V, Vizzielli G, Sozzi G, Beretta P, Steinkasserer M, Legge F, Stevenazzi G, Candotti G, Bergamini V, Fanfani F, Garzon S. A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial. Int J Gynecol Cancer. 2024 Dec 2;34(12):1971-1975. doi: 10.1136/ijgc-2024-005668. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |