The HYSTER study: the effect of intracervically administered terlipressin versus placebo on the number of gaseous emboli and fluid intravasation during hysteroscopic surgery: study protocol for a randomized controlled clinical trial

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2442-9) contains supplementary material, which is available to authorized users.

A Romanian study on the impact of glypressin in laparoscopic myomectomy

“…In addition, in the Netherlands, the use of terlipressin in minimally invasive gynecological interventions has become a common practice. In 2018, Overdijk et al in a double-blind randomized trial suggested that glypressin may decrease the intravasation and gaseous embolism in hysteroscopic surgery, reducing the need for performing the intervention in two steps (29).…”

Hysteroscopy and the risk of gas embolism: A review

“…Therefore, based on this theory, there is currently a randomized controlled trial being performed in the Netherlands investigating whether paracervical terlipressin will lead to a reduction in intravasation and hence a reduction in gas emboli. 22 A total of 48 patients will be randomized to either treatment or placebo during operative hysteroscopy. A transesophageal echocardiogram will be performed during the surgery with the primary endpoint being how terlipressin affects the severity of embolic events.…”

The effect of vasopressin during hysteroscopic myomectomy in patients with submucosal myoma: A randomized controlled trial

“…Some studies showed that the intracervical administration of vasopressin reduces the amount of blood loss and low-viscosity distension fluid absorbed due to its vasoconstrictive effect. [ 10 11 ] The management of blood loss during surgery reduces the operative time and improves the visual clarity. [ 12 13 14 ] The aim of the present study was to assess the effect of vasopressin in reducing the time of surgery, fluid deficit, visual clarity, and amount of bleeding.…”