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

What Was Tested

The paper reports a study of Terlipressin, published as a clinical study.

However, intravasation of distension fluid is a common phenomenon during these procedures.

In a previous study the researchers observed venous gas emboli in almost every patient.

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults and older adults, women only.

Forty-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.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Terlipressin could be set against what happens without it.

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.

Their 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.

What Was Measured

Topics PubMed links to this paper include Drug Administration Routes, Echocardiography, Transesophageal, Embolism, Air, Hemodynamics, Hysteroscopy, Myoma and Netherlands.

Author keywords: Hysteroscopic surgery, Intravasation, Terlipressin, Transcervical resection of endometrium and Transcervical resection of myomas.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Terlipressin.

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (Trials), a journal based in England.

More context: the Terlipressin compound page, all human trials.