Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT00683293
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy
Sponsor:
Kantonsspital Aarau
Organization:
Study Overview
Official Title:
Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.
Detailed Description:
During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.
Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.
Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: