Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy

Kantonsspital Aarau

Status: Completed

Conditions: Postoperative Complications; Intraoperative Complications; Laparoscopic Technique no Switch to Open; Duration of Surgery

Treatments: Procedure: Conventional Laparoscopic Hysterectomy; Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00683293

KSA-RobHyst

Details and patient eligibility

About

The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

1

Active Comparator group

Description:

Randomized group of patients receiving conventional laparoscopic hysterectomy

Treatment:

Procedure: Conventional Laparoscopic Hysterectomy

2

Active Comparator group

Description:

Randomized group of patients receiving robot-assisted laparoscopic hysterectomy

Treatment:

Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy