Condition category
Surgery
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl/vesselseal/

Contact information

Type

Scientific

Primary contact

Prof. A.M. BrÖlmann

ORCID ID

Contact details

Vrije University Medical Centre (VUMC)
De Boelelaan 1117
Amsterdam
-
Netherlands
+31 (0)20 4444851
h.brolmann@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The vessel seal instrument results in shorter operating time and less intraoperative bloodloss than the conventional bipolar coagulation in patients undergoing laparoscopic hysterectomy and/or salpingo-oophorectomy

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, multicentre, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Vessel seal, hysterectomy, laparoscopy, oophorectomy

Intervention

Hemostasis with vessel seal technique versus conventional technique.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Operating time
2. Intraoperative bloodloss

Secondary outcome measures

1. Haemoglobin drop
2. User satisfaction
3. Costs
4. Quality of life, measured using the 36-item Short Form health survey (SF36)

Overall trial start date

01/01/2007

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Laparoscopic hysterectomy
2. Laparoscopic oophorectomy

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

144

Participant exclusion criteria

1. Ovarian or cervical cancer
2. Uterus size greater than 20 weeks pregnancy

Recruitment start date

01/01/2007

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre (VUMC)
Amsterdam
-
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/#http://www.vumc.nl/english/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes