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van CCT (UK)


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van CCT (UK)


The effect of administration of terlipressine in the cervix of the uterus on the amount of uptake of fluid, formation of gas bubbles and the circulation during hysteroscopy


- candidate number23502
- NTR NumberNTR5577
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-dec-2015
- Secondary IDsWO11.110  Eudra CT 2013-000006-28 ABR 45004
- Public TitleThe effect of administration of terlipressine in the cervix of the uterus on the amount of uptake of fluid, formation of gas bubbles and the circulation during hysteroscopy
- Scientific TitleReducing gas embolism during hysteroscopic surgery by limiting the amount of intravasation with the installation of intracervical terlipressin
- ACRONYMHYSTER
- hypothesisIntracervical installation of terlipressin reduces the incidence and severity of gas embolsim and the amount of intravasation during hysteroscopic surgery
- Healt Condition(s) or Problem(s) studiedMyoma, Menorrhagia
- Inclusion criteria48 patiens (ASA classification 1 or 2) secheduled for trans cervical resection of large type 1-2 moma's (TCR-M) or extensive trans cervical endometrium resection (TCR-E)
- Exclusion criteriaTrans cervical operations of small myoma's and minor TCR-E procedures.
Short lasting procedures of < 1/2 hour.
Contraindication for transesophageal echocardiography (severe oesopageal or gastric disease, hepatic cirrhosis of known oesphageal varices.
Patients < 18 yr or > 70 yr.
Histroy of pulmonary embolism, cardiac disease or oesphageal disease. Patient wih language barrier.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2013
- planned closingdate31-dec-2016
- Target number of participants48
- InterventionsIntracervical installation of terlipressin vs placebo
- Primary outcometo determine whether the intracervical insallation of terlipressin reduces the inncidence and severity of gas embolsim as detected by trans oesophageal echocardiography (TOE)
- Secondary outcometo study the effect of intracervical terlipressin on the amont of intravasation, global hemodynamics, myocardial ventricular systolic strain and myocardial diastolic funcion using TOE. A substudy will be done analysing the laboratoy results to determine elceltrlyte changes and assessing acid-base disturbances.
- Timepointsduring surgery till 3 hours postoperative
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.E. Overdijk
- CONTACT for SCIENTIFIC QUERIES L.E. Overdijk
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summaryTCR-M an TCR-E are safe hysteroscopic minimal invasive procedures. However, in a previous study we observed by TOE venous gas embolsim in almost every patient. This might be a potentially dangerous phenomenon. Hysteroscopic derived gas embolism has been shown to be correlated to the amount of intravasation. The installation of intracervical vasopressin has been shown to limit the amount of intravasation, therefore its use may be beneficial in hysteroscopic surgery leading to a lower incidence and severity of gas embolism. We use terlipressin (a synthetic long acting analogue of vasopressin)instead of vasopressin because vaspressin is not avalibale in our country, assuming terlipressine has the same effect on intravasation.
- Main changes (audit trail)
- RECORD18-dec-2015 - 14-feb-2016


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