Reducing Gas Embolisation During Hysteroscopic Surgery by limiting the amount of intravasation with the installation of intracervical terlipressin (HYSTER)

Completed

Conditions: menorrhagia
myoma
vaginal bleeding
10013326

Registration Number: NL-OMON41343

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

ASA classification 1 or 2, scheduled for trans cervical resection of large type 1-2 myoma*s (TCR-M) or extensive trans cervical endometrium resection (TCR-E)

Exclusion Criteria

- Patients undergoing trans cervical operations of small myoma*s and minor TCR-E procedures.
- Procedures that are expected to be short lasting (less than * hour) are excluded.
- Patient with a known contraindication for TEE such as severe oesophageal or gastric disease, hepatic cirrhosis of known oesophageal varices
- Patients younger than 18 yr or older than 70 yr
- Patients with a history of pulmonary embolism, cardiac disease or oesophageal disease
- Patients with language barrier will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the appearance of venous embolism either venous<br>or paradoxical of origin. The severity of the embolism will be assessed using a<br>five point grading scale. In addition, the duration of the embolic phenomena<br>will be recorded.</p>

Secondary Outcome Measures

Name	Time	Method
<p>1.For assessment of hemodynamics derived from embolic events or from possible<br>systemic effects of terlipressin.<br><br>•Global hemodynamics will be measured with a non-invasive beat to beat<br>hemodynamic monitor Nexfin HD (BMEYE B.V, Amsterdam, Netherlands) providing<br>continuous data including blood pressure, cardiac output and systemic vascular<br>resistance.<br>•Measurements of systolic and diastolic cardiac function will be assessed by<br>TOE before and just after surgery.<br><br>2.For assessment of effects of terlipressin on intravasation<br><br>•Intravasation will be calculated by subtracting the amount of fluid introduced<br>via the resectoscope and the amount of fluid collected by fluid suction.<br>•Intravasation will be calculated by assessment of changes of haematocrit.<br><br><br>3. Analysis of electrolyt and acid base balance disturbances.</p>