Limits...
Intravenous tranexamic acid as an adjunct haemostat to ornipressin during open myomectomy. A randomized double blind placebo controlled trial.

Ngichabe S, Obura T, Stones W - Ann Surg Innov Res (2015)

Bottom Line: The options of conservative surgical approaches mainly aim at retention of fertility but have to be balanced against potential risks such as haemorrhage; blood loss at myomectomy still remains troublesome with use of various pharmacologic agents yielding inconclusive results.In settings such as ours where myomata are prevalent and severe anaemia rampant, blood donation and judicious use of scarce blood resources is key.PACTR201203000369163.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Aga Khan University, Nairobi, Kenya.

ABSTRACT

Background: Myomectomy is a surgical technique used for removal of uterine fibroids and historically hysterectomy has represented the mainstay of treatment. The options of conservative surgical approaches mainly aim at retention of fertility but have to be balanced against potential risks such as haemorrhage; blood loss at myomectomy still remains troublesome with use of various pharmacologic agents yielding inconclusive results. This trial aimed to explore the benefit of combining ornipressin and tranexamic acid during open myomectomy.

Study design: A randomized double blind placebo controlled trial.

Methods: Women who satisfied eligibility criteria were enrolled into the study and randomized into one of two groups. The experimental group received 1 g of tranexamic acid diluted to 50 ml of saline administered at 100 ml per hour at cutting time (knife to skin). The control group received placebo diluted to 50 ml of saline administered at 100 ml per hour at cutting time. Both groups had five international units ornipressin diluted in 60 ml of saline administered during surgery. The primary outcome (blood loss) was assessed by determining the weight difference of dry and soaked swabs using a digital weighing scale by converting this to volume (ml). Operating time was noted from the time of uterine incision to the time of uterine closure. The need for transfusion was determined by anaesthetists' assessment of acceptable blood loss and clinical assessment of vital signs. Post-operative stay was calculated from the time of extubation to 8 am on the day of discharge.

Results: A total of thirty-four patients were randomized to two groups; 17 received ornipressin only and 17 received tranexamic acid and ornipressin. There was no difference in blood loss between the groups with a median blood loss in the ornipressin (n = 17) and ornipressin plus tranexamic acid arms of 398 ml (IQR: 251-630) ml and 251 ml (IQR: 158-501) ml respectively P = 0.361.

Conclusions: Ornipressin administered along with tranexamic acid is not beneficial for blood loss reduction at open myomectomy. In settings such as ours where myomata are prevalent and severe anaemia rampant, blood donation and judicious use of scarce blood resources is key. Efforts to optimize preoperative haemoglobin levels and blood auto-donation seem the most promising options in pre-operative preparation prior to myomectomy.

Clinical trials registration number: PACTR201203000369163.

No MeSH data available.


Related in: MedlinePlus

Flow of study participants
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4644022&req=5

Fig1: Flow of study participants

Mentions: Participant flow for the study is shown in Fig. 1. Data were available for 17 participants in each group. Clinical and operative findings are presented in Table 1. Operating time and estimated blood loss are shown in Table 2. There were no major postoperative complications or study medication related adverse events in either group. Data analysis was performed using STATA version 12 special edition (STATA/SE). Categorical variables were summarized as frequencies (n) and the corresponding percentages (%) while the continuous variables that were normally distributed were summarized as mean and the corresponding standard deviation (std). Continuous variables that were skewed were transformed using the logarithm to base 10. The variables that were transformed were blood loss, operation time, and myoma volume. The test for differences between the categorical variables and the treatment group was conducted using the Pearson’s Chi Square test and because of the small cell counts for all the variables Fisher’s exact was utilized. The relationship between the continuous variables was assessed using Pearson’s correlation coefficient. The test for differences in the continuous variables between the treatment groups was done using the two-sample t test if the normality assumption was holding. However, if the normality assumption was violated, then a two sample Wilcoxon rank sum test was used. The test for differences in the continuous variables between the treatment groups was done using the two-sample t test. Assessment for the validity of a t test was also done.Fig. 1


Intravenous tranexamic acid as an adjunct haemostat to ornipressin during open myomectomy. A randomized double blind placebo controlled trial.

Ngichabe S, Obura T, Stones W - Ann Surg Innov Res (2015)

Flow of study participants
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4644022&req=5

Fig1: Flow of study participants
Mentions: Participant flow for the study is shown in Fig. 1. Data were available for 17 participants in each group. Clinical and operative findings are presented in Table 1. Operating time and estimated blood loss are shown in Table 2. There were no major postoperative complications or study medication related adverse events in either group. Data analysis was performed using STATA version 12 special edition (STATA/SE). Categorical variables were summarized as frequencies (n) and the corresponding percentages (%) while the continuous variables that were normally distributed were summarized as mean and the corresponding standard deviation (std). Continuous variables that were skewed were transformed using the logarithm to base 10. The variables that were transformed were blood loss, operation time, and myoma volume. The test for differences between the categorical variables and the treatment group was conducted using the Pearson’s Chi Square test and because of the small cell counts for all the variables Fisher’s exact was utilized. The relationship between the continuous variables was assessed using Pearson’s correlation coefficient. The test for differences in the continuous variables between the treatment groups was done using the two-sample t test if the normality assumption was holding. However, if the normality assumption was violated, then a two sample Wilcoxon rank sum test was used. The test for differences in the continuous variables between the treatment groups was done using the two-sample t test. Assessment for the validity of a t test was also done.Fig. 1

Bottom Line: The options of conservative surgical approaches mainly aim at retention of fertility but have to be balanced against potential risks such as haemorrhage; blood loss at myomectomy still remains troublesome with use of various pharmacologic agents yielding inconclusive results.In settings such as ours where myomata are prevalent and severe anaemia rampant, blood donation and judicious use of scarce blood resources is key.PACTR201203000369163.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, Aga Khan University, Nairobi, Kenya.

ABSTRACT

Background: Myomectomy is a surgical technique used for removal of uterine fibroids and historically hysterectomy has represented the mainstay of treatment. The options of conservative surgical approaches mainly aim at retention of fertility but have to be balanced against potential risks such as haemorrhage; blood loss at myomectomy still remains troublesome with use of various pharmacologic agents yielding inconclusive results. This trial aimed to explore the benefit of combining ornipressin and tranexamic acid during open myomectomy.

Study design: A randomized double blind placebo controlled trial.

Methods: Women who satisfied eligibility criteria were enrolled into the study and randomized into one of two groups. The experimental group received 1 g of tranexamic acid diluted to 50 ml of saline administered at 100 ml per hour at cutting time (knife to skin). The control group received placebo diluted to 50 ml of saline administered at 100 ml per hour at cutting time. Both groups had five international units ornipressin diluted in 60 ml of saline administered during surgery. The primary outcome (blood loss) was assessed by determining the weight difference of dry and soaked swabs using a digital weighing scale by converting this to volume (ml). Operating time was noted from the time of uterine incision to the time of uterine closure. The need for transfusion was determined by anaesthetists' assessment of acceptable blood loss and clinical assessment of vital signs. Post-operative stay was calculated from the time of extubation to 8 am on the day of discharge.

Results: A total of thirty-four patients were randomized to two groups; 17 received ornipressin only and 17 received tranexamic acid and ornipressin. There was no difference in blood loss between the groups with a median blood loss in the ornipressin (n = 17) and ornipressin plus tranexamic acid arms of 398 ml (IQR: 251-630) ml and 251 ml (IQR: 158-501) ml respectively P = 0.361.

Conclusions: Ornipressin administered along with tranexamic acid is not beneficial for blood loss reduction at open myomectomy. In settings such as ours where myomata are prevalent and severe anaemia rampant, blood donation and judicious use of scarce blood resources is key. Efforts to optimize preoperative haemoglobin levels and blood auto-donation seem the most promising options in pre-operative preparation prior to myomectomy.

Clinical trials registration number: PACTR201203000369163.

No MeSH data available.


Related in: MedlinePlus