Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
North Shore Medical Center
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01393704
First received: July 11, 2011
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: November 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Treatment
Condition: Blood Loss, Surgical
Intervention: Drug: Vasopressin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Volume Dilute Vasopressin

20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).

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

Low Volume Dilute Vasopressin

20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).

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


Participant Flow:   Overall Study
    High Volume Dilute Vasopressin   Low Volume Dilute Vasopressin
STARTED   76   76 
COMPLETED   76   76 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Volume Dilute Vasopressin

20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).

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

Low Volume Dilute Vasopressin

20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).

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

Total Total of all reporting groups

Baseline Measures
   High Volume Dilute Vasopressin   Low Volume Dilute Vasopressin   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   76   152 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      76 100.0%      76 100.0%      152 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.39  (5.68)   37.87  (7.11)   37.49  (6.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      76 100.0%      76 100.0%      152 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   76   76   152 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage   [ Time Frame: 5 minutes post-operatively ]

2.  Primary:   Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss   [ Time Frame: 5 minutes post-operatively ]

3.  Primary:   Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation   [ Time Frame: 5 minutes post-operatively ]

4.  Secondary:   Number of Participants With Peri-operative Complications   [ Time Frame: 8 weeks postoperatively ]

5.  Secondary:   Total Operation Time   [ Time Frame: 5 minutes postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to practice pattern differences among sites, there was some missing data for the change in hematocrit variable, and a smaller amount of data missing for suction canister blood loss calculation.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jon Einarsson
Organization: Brigham and Women's Hospital
phone: 617-525-8582
e-mail: jeinarsson@partners.org



Responsible Party: Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01393704     History of Changes
Other Study ID Numbers: 2011-P-000264/1
Study First Received: July 11, 2011
Results First Received: November 28, 2016
Last Updated: April 7, 2017