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 |
| Secondary identifying numbers | NL939 (NTR964) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.M. BrÖlmann
Scientific
Scientific
Vrije University Medical Centre (VUMC)
De Boelelaan 1117
Amsterdam
-
Netherlands
| Phone | +31 (0)20 4444851 |
|---|---|
| h.brolmann@vumc.nl |
Study information
| Study design | Randomised, multicentre, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2007 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
-
Netherlands
-
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/#http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/09/2011 | 19/10/2021 | Yes | No |
Editorial Notes
19/10/2021: Publication reference added.
