Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

What Was Tested

The trial (phase 4) is built around Vasopressin.

The main purpose of this study is to compare blood loss at the time of laparoscopic or robotically-assisted laparoscopic myomectomy when using different amounts of dilute vasopressin solution.

Myomectomy is a surgical procedure to remove fibroids from the uterus.

It had two arms (groups): High Volume Dilute Vasopressin (active comparator) and Low volume dilute vasopressin (active comparator).

The registry classes the interventions as drug.

More on the Plan

All surgeons who enroll patients into their study are experienced laparoscopic surgeons who have performed at least 100 advanced laparoscopic procedures including hysterectomies and myomectomies.

Briefly, their laparoscopic myomectomy technique is as follows: After gaining peritoneal access and placing visual and operative trocars, the surgical site is inspected carefully and fibroid locations identified.

Patients will be randomized one of two treatment groups pre-operatively on the day of surgery: 1.

The procedure is done according to surgeon preference using various energy modalities such as monopolar or Harmonic Scalpel® (Ethicon Endo-Surgery, Cincinnati OH), for making the incision in the uterus.

Who Took Part

152 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Vasopressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-07 with completion listed for 2015-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage (time frame: 5 minutes post-operatively). Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss (time frame: 5 minutes post-operatively). Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation (time frame: 5 minutes post-operatively).

It also tracked 2 secondary outcomes, for example Number of Participants With Peri-operative Complications and Total Operation Time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in 152 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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