Plain English Summary
Not provided at time of registration
Trial website
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
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