UMIN ID: UMIN000032950
Registered date:11/06/2018
Laparoscopic approach in high-risk patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Women who require gynecological surgery that are classified as at high risk at the pre-surgical evaluation have significant morbidity. |
| Date of first enrollment | 2015/03/03 |
| Target sample size | 10000 |
| Countries of recruitment | Europe |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Intraoperative data (operation time, blood loss, intraoperative complications, need for laparotomic conversion), postoperative data (fever, need for re-intervention, hospital stay) and readmission. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Primary indication to vaginal, laparotomic, and hysteroscopic surgery |
Related Information
| Primary Sponsor | Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Marco Scioscia |
| Address | Via Sempreboni 5 - 37024 Negrar (VR), Italy |
| Telephone | +393498724206 |
| marcoscioscia@gmail.com | |
| Affiliation | Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy Obstetrics and Gynecology |
| scientific contact | |
| Name | Marco Scioscia |
| Address | Via Sempreboni 5 - 37024 Negrar (VR), Italy |
| Telephone | +393498724206 |
| marcoscioscia@gmail.com | |
| Affiliation | Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy Obstetrics and Gynecology |