Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

NCT01393704 | Completed Phase 4 Results

• 1 other identifier: 2011-P-000264/1
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myomectomy; vasopressin; blood loss

Outcome Measures

Primary Outcomes (3)

• Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage

  To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.

  5 minutes post-operatively

• Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss

  To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.

  5 minutes post-operatively

• Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation

  To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = \[total suction canister volume\] - \[volume of irrigation used\] - \[volume of vasopressin solution injected /2\].

  5 minutes post-operatively

Secondary Outcomes (2)

• Number of Participants With Peri-operative Complications

  8 weeks postoperatively

• Total Operation Time

  5 minutes postoperatively

Study Arms (2)

High Volume Dilute Vasopressin

ACTIVE COMPARATOR

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).

Drug: Vasopressin

Low volume dilute vasopressin

ACTIVE COMPARATOR

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).

Drug: Vasopressin

Interventions

Vasopressin DRUG

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

Also known as: Pitressin

High Volume Dilute Vasopressin; Low volume dilute vasopressin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• North Shore Medical Center: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Brigham&Women's hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Diabetes Insipidus; Hemorrhage

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jon Einarsson
• Organization: Brigham and Women's Hospital

jeinarsson@partners.org

617-525-8582

Study Officials

• Jon I Einarsson, MD,MPH.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Minimally Invasive Gynecology

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 13, 2011
• Study Start: July 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 15, 2018
• Results First Posted: April 10, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)