Abstract
BackgroundTranscervical resection of myoma or endometrium is a safe, hysteroscopic, minimally invasive procedure. However, intravasation of distension fluid is a common phenomenon during these procedures. In a previous study we observed venous gas emboli in almost every patient. The severity of hysteroscopic-derived embolization has been shown to be correlated to the amount of intravasation. In addition, paradoxical gas embolism, which is potentially dangerous, was observed in several patients.Studies have shown a reduction of intravasation by using intracervically administered vasopressin during hysteroscopy. We think that its analog, terlipressin, should have the same effect. In our previous research we observed more gaseous emboli as intravasation increased. Whether or not the insertion of intracervically administered terlipressin leads to a lower incidence and severity of gas embolism is unknown. We hypothesize that intracervically administered terlipressin leads to a reduction of intravasation with a lower incidence and severity of gas embolism. Terlipressin may be of benefit during hysteroscopic surgery.Methods/designForty-eight patients (ASA 1 or 2) scheduled for transcervical resection of large, types 1–2 myoma or extensive endometrium resection will be included. In a double-blind fashion patients will be randomized 1:1 according to surgical treatment using either intracervically administered terlipressin or placebo. Transesophageal echocardiography will be used to observe and record embolic events. A pre- and post-procedure venous blood sample will be taken to calculate intravasation based on hemodilution. Our primary endpoint will be how terlipressin influences the severity of embolic events. Secondary endpoints include the effect of terlipressin on the amount of intravasation and on hemodynamic parameters.DiscussionIf terlipressin does indeed reduce the number of gaseous emboli and intravasation occurring during hysteroscopic surgery, it would be a simple method to minimize potential adverse events. It also allows for prolonged operating time before the threshold of intravasation is reached, thereby reducing the need for a second operation.Trial registrationNederlands Trial Register (Dutch Trial Register), ID: NTR5577. Registered retrospectively on 18 December 2015.
Highlights
Transcervical resection of myoma or endometrium is a safe, hysteroscopic, minimally invasive procedure
If terlipressin does reduce the number of gaseous emboli and intravasation occurring during hysteroscopic surgery, it would be a simple method to minimize potential adverse events
As legally required a liability insurance covers potential physical harm inflicted to patients through study procedures. This protocol describes a double-blind randomized trial to compare the effect of intracervically administered terlipressin with placebo in regard to the degree of gaseous embolism and intravasation during hysteroscopic surgery
Summary
Transcervical resection of myoma or endometrium is a safe, hysteroscopic, minimally invasive procedure. Whether or not the insertion of intracervically administered terlipressin leads to a lower incidence and severity of gas embolism is unknown. We hypothesize that intracervically administered terlipressin leads to a reduction of intravasation with a lower incidence and severity of gas embolism. Risks and complications during hysteroscopy are rare [1–3] serious complications include fluid overload by intravasation of large amounts of distension fluid and the occurrence of air or gaseous emboli which can be potentially life threatening [3–12]. We observed paradoxical embolism with the passage of venous air or gas into the arterial circulation [13]. This may account for some of the described cardiovascular and neurological symptoms associated with large venous emboli. One case of temporary blindness has been associated with paradoxical embolism [10]
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