Haemostasis with vessel seal instrument compared to conventional bipolar coagulation in laparascopic hysterectomy and/or salpingo-ooforectomy: a randomised trial

ISRCTN	ISRCTN80747160
DOI	https://doi.org/10.1186/ISRCTN80747160
Protocol serial number	NL939 (NTR964)
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A.M. BrÖlmann
Scientific

Vrije University Medical Centre (VUMC)
De Boelelaan 1117
Amsterdam
-
Netherlands

Phone	+31 (0)20 4444851
Email	h.brolmann@vumc.nl

Primary study design	Interventional
Study design	Randomised, multicentre, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Haemostasis with vessel seal instrument compared to conventional bipolar coagulation in laparascopic hysterectomy and/or salpingo-ooforectomy: a randomised trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Vessel seal, hysterectomy, laparoscopy, oophorectomy
Intervention	Hemostasis with vessel seal technique versus conventional technique.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Operating time 2. Intraoperative bloodloss
Key secondary outcome measure(s)	1. Haemoglobin drop 2. User satisfaction 3. Costs 4. Quality of life, measured using the 36-item Short Form health survey (SF36)
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	144
Key inclusion criteria	1. Laparoscopic hysterectomy 2. Laparoscopic oophorectomy
Key exclusion criteria	1. Ovarian or cervical cancer 2. Uterus size greater than 20 weeks pregnancy
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2008

Vrije University Medical Centre (VUMC)

Amsterdam
-
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		06/09/2011	19/10/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

19/10/2021: Publication reference added.