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

NCT ID: NCT00683293

Last Updated: 2014-04-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Randomized group of patients receiving conventional laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

Conventional Laparoscopic Hysterectomy

Intervention Type PROCEDURE

Removal of uterus via standard laparoscopic techniques

2

Randomized group of patients receiving robot-assisted laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

Robot-assisted (Da Vinci®) laparoscopic hysterectomy

Intervention Type PROCEDURE

Removal of uterus by robot-assisted laparoscopic technique

Interventions

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Conventional Laparoscopic Hysterectomy

Removal of uterus via standard laparoscopic techniques

Intervention Type PROCEDURE

Robot-assisted (Da Vinci®) laparoscopic hysterectomy

Removal of uterus by robot-assisted laparoscopic technique

Intervention Type PROCEDURE

Other Intervention Names

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- Minimal invasive hysterectomy, - Laparoscopic removal of uterus, - Minimal invasive removal of uterus - Robot-assisted(Da Vinci®)laparoscopic hysterectomy - Robot-assisted minimal invasive hysterectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role lead

Responsible Party

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Dimitri Sarlos

Head Gynaecology and oncological Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitri Sarlos, MD

Role: STUDY_CHAIR

Kantonsspital Aarau

Locations

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Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 22914470 (View on PubMed)

Other Identifiers

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KSA-RobHyst

Identifier Type: -

Identifier Source: org_study_id

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