Intracervical installation of terlipressin reduces the incidence and severity of gas embolsim and the amount of intravasation during hysteroscopic surgery
ID
Bron
Verkorte titel
Aandoening
myoma. menorrhagia
Ondersteuning
OLVG, Oosterpark 9, 1091 AC Amsterdam, l.e.overdijk@olvg.nl, 020-599111
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
to determine whether the intracervical insallation of terlipressin reduces the inncidence and severity of gas embolsim as detected by trans oesophageal echocardiography (TOE)
Achtergrond van het onderzoek
TCR-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.
Doel van het onderzoek
Intracervical installation of terlipressin reduces the incidence and severity of gas embolsim and the amount of intravasation during hysteroscopic surgery
Onderzoeksopzet
during surgery till 3 hours postoperative
Onderzoeksproduct en/of interventie
Intracervical installation of terlipressin vs placebo
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
48 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Trans 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.
Opzet
Deelname
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Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5344 |
| NTR-old | NTR5577 |
| EudraCT | EUCTR2013-000006-28-NL |
| CCMO | NL45004.100.13 |
| OMON | NL-OMON41343 |