Trial Outcomes & Findings for Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial (NCT NCT01393704)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

152 participants

Primary outcome timeframe

5 minutes post-operatively

Results posted on

2018-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	76	76
Overall Study COMPLETED	76	76
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Volume Dilute Vasopressin n=76 Participants 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 n=76 Participants 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 n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	76 Participants n=7 Participants	152 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.39 years STANDARD_DEVIATION 5.68 • n=5 Participants	37.87 years STANDARD_DEVIATION 7.11 • n=7 Participants	37.49 years STANDARD_DEVIATION 6.39 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	76 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	76 participants n=7 Participants	152 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes post-operatively

Population: Due to practice pattern differences among sites, there was some missing data for the change in hematocrit variable, where the hematocrit either pre-operatively or post-operatively was not collected.

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.

Outcome measures

Outcome measures
Measure	High Volume Dilute Vasopressin n=45 Participants 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 n=46 Participants 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.
Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage	-4.4 hematocrit percentage Standard Deviation 3.9	-4.0 hematocrit percentage Standard Deviation 3.2

PRIMARY outcome

Timeframe: 5 minutes post-operatively

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.

Outcome measures

Outcome measures
Measure	High Volume Dilute Vasopressin n=76 Participants 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 n=76 Participants 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.
Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss	106.2 millileters Standard Deviation 3.0	119 millileters Standard Deviation 3.2

PRIMARY outcome

Timeframe: 5 minutes post-operatively

Population: Due to practice pattern differences among sites, there was some missing data for suction canister blood loss calculation. In these cases, total suction canister volume and/or volume of irrigation used were not measured.

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 = \[total suction canister volume\] - \[volume of irrigation used\] - \[volume of vasopressin solution injected /2\].

Outcome measures

Outcome measures
Measure	High Volume Dilute Vasopressin n=63 Participants 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 n=61 Participants 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.
Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation	178 millileters Standard Deviation 265	198 millileters Standard Deviation 232

SECONDARY outcome

Timeframe: 8 weeks postoperatively

Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).

Outcome measures

Outcome measures
Measure	High Volume Dilute Vasopressin n=76 Participants 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 n=76 Participants 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.
Number of Participants With Peri-operative Complications	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 5 minutes postoperatively

Time from incision to end of surgery

Outcome measures

Outcome measures
Measure	High Volume Dilute Vasopressin n=76 Participants 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 n=76 Participants 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 Operation Time	176.8 minutes Standard Deviation 82.09	165.5 minutes Standard Deviation 70.26

Adverse Events

High Volume Dilute Vasopressin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Volume Dilute Vasopressin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jon Einarsson

Brigham and Women's Hospital

Phone: 617-525-8582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place