| - candidate number | 2568 |
| - NTR Number | NTR964 |
| - ISRCTN | ISRCTN80747160 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 1-mei-2007 |
| - Secondary IDs | |
| - Public Title | Hemostasis with vesselsealinstrument compared to conventional bipolar coagulation in laparascopic hysterectomy and/or salpingo-ooforectomy. a randomised trial |
| - Scientific Title | N/A |
| - ACRONYM | N/A |
| - hypothesis | The vesselseal instrument results in shorter operating time and less intraoperative bloodloss than the conventional bipolar coagulation in patients undergoing laparoscopic hysterectomy and/or salpingo-oophorectomy |
| - Healt Condition(s) or Problem(s) studied | Vesselseal, Laparoscopy, Hysterectomy, Ovariectomy |
| - Inclusion criteria | 1. Laparoscopic hysterectomy; 2. Laparoscopic oophorectomy |
| - Exclusion criteria | 1. Ovarian or cervical cancer; 2. Uterus size > 20 weeks pregnancy |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 1-jan-2008 |
| - Target number of participants | 144 |
| - Interventions | Hemostasis with vesselseal technique |
| - Primary outcome | 1. Operating time; 2. Intraoperative bloodloss |
| - Secondary outcome | 1. Hemoglobin drop; 2. User satisfaction; 3. Costs; 4. Quality of life (SF36) |
| - Timepoints | |
| - Trial web site | http://www.studies-obsgyn.nl/vesselseal/ |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Professor H.A.M. Brölmann |
| - CONTACT for SCIENTIFIC QUERIES | Professor H.A.M. Brölmann |
| - Sponsor/Initiator | VU University Medical Center, Department of Obstetrics and Gynaecology |
| - Funding (Source(s) of Monetary or Material Support) | |
| - Publications | Articles on (laparoscopic) hysterectomy Brölmann Brölmann HAM. Laparoscopische assistentie bij hysterectomie; modus of mode. Ned T Obstetrie en Gynaecologie 1995;108:365 – 366 HAM Brölmann, S de Blok, IMHE Buijs. Van kijkbuis naar doebuis; de gevolgen voor de hysterectomie. Ned T Obstet Gynaecol 1996;109:313 – 316 Derksen JGM, Brölmann HAM, Wiegerinck, Vader HL, Heintz APM. The effect of hysterectomy and endometrial ablation on follicle stimulating hormone (FSH) levels up to 1 year after surgery. Maturitas 1998;29:133 – 138 HAM Brölmann, MY Bongers. Resultaten van laparoscopisch geassisteerde vaginale hysterectomieen in het Ikazia Ziekenhuis te Rotterdam, 1993-1997 (ingezonden brief). Ned T Geneesk 1998;142:2431 HAM Brölmann. Wel of niet sluiten van het peritoneum na een vaginale hysterectomie. NTOG 2000;113:231 - 232 HAM Brölmann. Vasopressin during abdominal hysterectomy reduced bloodloss by 40 % (commentary). J Evidence Based Obstetrics and Gynecology 2002;2:78-9 HAM Brölmann, MY Bongers, GL Bremer, PCM van der Salm. A randomised comparison and economic evaluation in laparoscopic assisted hysterectomy and abdomminal hysterectomy. (correspondence). Brit J Obstet Gynaecol 2002;109:1427-28. Brölmann HAM. Laparoscpic hysterectomy had a higher rate of major complications than abdominal hysterectomy (comment). Evidence based Obstet Gynecol 2004;6:122-24. Kluivers KB, Bongers MY, Mol BWI, Bremer GL, Weemhoff m, Brölmann HAM, Withagen MIJ, Vierhout ME. Pevic organ function in randomised laparoscopic and abdominal hysterectomy patients. Poster ESGE Annual Congress, Strassbourg, October 2006 |
| - Brief summary | Laparoscopic hysterectomy and/or oophorectomy undergo a slow but steady implementation in the Netherlands. Hemostasis in laparoscopic surgery is sometimes problematic with the conventional methods, such as bipolar coagulation. Since recently a new vesselsela technique is commercially available. The objective of the technique is to close the vessel quicker and more effective. This should result in shorter operating time and less bloodloss. This hypothesis is tested in the current study. |
| - Main changes (audit trail) | |
| - RECORD | 1-mei-2007 - 11-jun-2007 |
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