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| Name | Class |
|---|---|
| Fagotti, Anna, M.D. | INDIV |
| Fanfani, Francesco, M.D. | INDIV |
| Salvatore Gueli Alletti | UNKNOWN |
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Phase II multicentric study
The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Interval Debulking Surgery | Experimental | Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic interval debulking surgery | Procedure | Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered |
| Measure | Description | Time Frame |
|---|---|---|
| Operative complication rate | Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | time to recurrence | one year |
| Overall Survival | time to last follow up/death | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Scambia, Prof | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart Rome, | Rome | Rome | 00100 | Italy | ||
| Policlinico Agostino Gemelli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26529370 | Derived | Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Ercoli A, Scambia G, Fagotti A. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study. Am J Obstet Gynecol. 2016 Apr;214(4):503.e1-503.e6. doi: 10.1016/j.ajog.2015.10.922. Epub 2015 Oct 31. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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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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|
|
| Rome |
| Rome |
| 00168 |
| Italy |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |