UMIN ID: UMIN000055466
Registered date:10/09/2024
A Non-Randomized Controlled Trial to Assess the Safety of Robotic Surgery Performed by Young Pediatric Surgeons
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | congenital biliary dilatation |
| Date of first enrollment | 2025/04/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Young pediatric surgeons who are not board certified in pediatric surgery will perform the surgery under the supervision of a robotic surgical proctor. Certified pediatric surgeons will perform the surgery. |
Outcome(s)
| Primary Outcome | Frequency of postoperative adverse events (Clavien-Dindo classification III or higher) |
|---|---|
| Secondary Outcome | Operating time, blood loss, postoperative hospital stay |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Excludes perforated cases or cases weighing less than 10kg. |
Related Information
| Primary Sponsor | Nagoya university |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuki Ota |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Japan Japan 4668550 |
| Telephone | 0527412111 |
| ota.kazuki@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Department of pediatric surgery |
| scientific contact | |
| Name | Kazuki Ota |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Japan Japan |
| Telephone | 0527412111 |
| ota.kazuki@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University Graduate School of Medicine Department of pediatric surgery |