MedTrace Logo

Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

NCT01393704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2018-02-15

Study results available
· View outcomes & findings →

Summary

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. Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic surgery; although very little is know about the optimal dosage and administration.

The investigators plan to perform a randomized clinical trial on patients scheduled for minimally invasive myomectomy. All patients will get the same overall amount of vasopressin. Patients will be assigned by chance to one of two groups: one group will receive higher volume of a more dilute vasopressin solution. The other group will receive a lower volume of a more concentrated solution. The investigators will collect information on operative blood loss and complications related to surgery.

Conditions

  • Blood Loss, Surgical

Interventions

DRUG

Vasopressin

Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • North Shore Medical Center

    collaborator OTHER

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jon I Einarsson, MD,MPH. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393704 on ClinicalTrials.gov