Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Randomized group of patients receiving conventional laparoscopic hysterectomy |
|
| 2 | Active Comparator | Randomized group of patients receiving robot-assisted laparoscopic hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Laparoscopic Hysterectomy | Procedure | Removal of uterus via standard laparoscopic techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Surgery | •Mean Time to complete surgery from cut to suture | after surgey |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | up to 2 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitri Sarlos, MD | Kantonsspital Aarau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22914470 | Result | Sarlos D, Kots L, Stevanovic N, von Felten S, Schar G. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):604-11. doi: 10.1097/AOG.0b013e318265b61a. |
Not provided
Not provided
Not provided
2008 to 2011 All patients were recruited from our clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 Conventional Laparoscopic Hysterectomy | Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques |
| FG001 | 2 Robot-assisted Laparoscopic Hysterectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Robot-assisted (Da Vinci®) laparoscopic hysterectomy | Procedure | Removal of uterus by robot-assisted laparoscopic technique |
|
|
group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 Conventional Laparoscopic Hysterectomy | Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques |
| BG001 | 2 Robot-assisted Laparoscopic Hysterectomy | group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Surgery | •Mean Time to complete surgery from cut to suture | Posted | Mean | Standard Deviation | minutes | after surgey |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Complications | Posted | Number | participants | up to 2 weeks |
|
|
2008 to 2011
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Conventional Laparoscopic Hysterectomy | Randomized group of patients receiving conventional laparoscopic hysterectomy Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques | 0 | 48 | 0 | 48 | ||
| EG001 | 2 Robot-assisted Laparoscopic Hysterectomy | group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization | 0 | 47 | 0 | 47 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dimtri SARLOS | Kantonsspital Aarau | 00418384141 | la.kots@ksa.ch |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|