Duration of Surgery, Intraoperative Complications, Laparoscopic Technique no Switch to Open, Postoperative Complications
Conditions
Keywords
Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery
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.
Interventions
Removal of uterus via standard laparoscopic techniques
PROCEDURERobot-assisted (Da Vinci®) laparoscopic hysterectomy
Removal of uterus by robot-assisted laparoscopic technique
Sponsors
Kantonsspital Aarau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Indication for laparoscopic hysterectomy * Patients BMI \< 40 * Signed consent
Exclusion criteria
* Estimated uterus weight \>400 g * No combination with other procedures * No underlying malignant condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Surgery | after surgey | •Mean Time to complete surgery from cut to suture |
Secondary
| Measure | Time frame |
|---|---|
| Complications | up to 2 weeks |
Countries
Switzerland
Participant flow
Recruitment details
2008 to 2011 All patients were recruited from our clinic
Participants by arm
| Arm | Count |
|---|---|
| 1 Conventional Laparoscopic Hysterectomy Randomized group of patients receiving conventional laparoscopic hysterectomy
Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques | 50 |
| 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 | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | 2 Robot-assisted Laparoscopic Hysterectomy | 1 Conventional Laparoscopic Hysterectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 4.2 | 45.8 years STANDARD_DEVIATION 6 | 46 years STANDARD_DEVIATION 5.1 |
| Region of Enrollment Switzerland | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 |
Outcome results
Primary
Duration of Surgery
•Mean Time to complete surgery from cut to suture
Time frame: after surgey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Conventional Laparoscopic Hysterectomy | Duration of Surgery | 75 minutes | Standard Deviation 21 |
| 2 Robot-assisted Laparoscopic Hysterectomy | Duration of Surgery | 106 minutes | Standard Deviation 29 |
Secondary
Complications
Time frame: up to 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Conventional Laparoscopic Hysterectomy | Complications | 4 participants |
| 2 Robot-assisted Laparoscopic Hysterectomy | Complications | 5 participants |