Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)
Sponsor
University of Palermo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05322265
Collaborator
Fundacio Puigvert (Other)
350
1
61.9
5.7
Study Details
Study Description
Brief Summary
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
the aim of this study is clarify complication and their resolution in laparoscopic renal and adrenal surgery.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
350 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS): an International Multicenter Study
Actual Study Start Date
:
Apr 1, 2017
Actual Primary Completion Date
:
Mar 31, 2022
Anticipated Study Completion Date
:
May 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| complicated patients patients underwent to laparoscopic renal and adrenal surgery with intraoperative complications |
Procedure: laparoscopic surgery for renal and adrenal diseases
type of treatment for patients underwent to laparoscopic surgery for renal and adrenal diseases with intraoperative complications
|
| uncomplicated patients patients underwent to laparoscopic renal and adrenal surgery with no complication during surgical procedure |
Outcome Measures
Primary Outcome Measures
- intraoperative complications [5 years]
evaluation of intraoperative complication and their resolution
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
renal diseases with indication to surgery adrenal masses
Exclusion Criteria:
open surgery in principle
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Palermo | Palermo | Italy | 90127 |
Sponsors and Collaborators
- University of Palermo
- Fundacio Puigvert
Investigators
- Study Director: Antonino Agrusa, Medicine, University of Palermo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Prof. Antonino Agrusa,
full professor of surgery,
University of Palermo
ClinicalTrials.gov Identifier:
NCT05322265
Other Study ID Numbers:
- CLARAS study
First Posted:
Apr 11, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Antonino Agrusa,
full professor of surgery,
University of Palermo
Additional relevant MeSH terms: