NCT00683293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

April 16, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

May 21, 2008

Results QC Date

November 12, 2013

Last Update Submit

March 11, 2014

Conditions

Laparoscopic Technique no Switch to OpenDuration of SurgeryIntraoperative ComplicationsPostoperative Complications

Keywords

Laparoscopic HysterectomyRobot-assisted Laparoscopic HysterectomyRobot-assisted Surgery

Outcome Measures

Primary Outcomes (1)

  • Duration of Surgery

    •Mean Time to complete surgery from cut to suture

    after surgey

Secondary Outcomes (1)

  • Complications

    up to 2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Randomized group of patients receiving conventional laparoscopic hysterectomy

Procedure: Conventional Laparoscopic Hysterectomy

2

ACTIVE COMPARATOR

Randomized group of patients receiving robot-assisted laparoscopic hysterectomy

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

Interventions

Conventional Laparoscopic HysterectomyPROCEDURE

Removal of uterus via standard laparoscopic techniques

Also known as: - Minimal invasive hysterectomy,, - Laparoscopic removal of uterus,, - Minimal invasive removal of uterus
1
Robot-assisted (Da Vinci®) laparoscopic hysterectomyPROCEDURE

Removal of uterus by robot-assisted laparoscopic technique

Also known as: - Robot-assisted(Da Vinci®)laparoscopic hysterectomy, - Robot-assisted minimal invasive hysterectomy
2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for laparoscopic hysterectomy
  • Patients BMI \< 40
  • Signed consent

You may not qualify if:

  • Estimated uterus weight \>400 g
  • No combination with other procedures
  • No underlying malignant condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22914470RESULT

MeSH Terms

Conditions

Intraoperative ComplicationsPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dimtri SARLOS
Organization
Kantonsspital Aarau
la.kots@ksa.ch
00418384141

Study Officials

  • Dimitri Sarlos, MD

    Kantonsspital Aarau

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Gynaecology and oncological Gynaecology

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

April 16, 2014

Results First Posted

April 16, 2014

Record last verified: 2014-03

Locations

CH(1)