Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05154279 |
| Other study ID # |
Elbanna_005 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2022 |
| Est. completion date |
March 30, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Wael Elbanna Clinic |
| Contact |
Wael El Banna |
| Phone |
01227760402 |
| Email |
waelelbanna[@]drwaelelbanna.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Our study aims to evaluate the efficacy of intramyometrial injection of Terlipressin versus
intramyometrial injection of Carbetocin on hemoglobin level in women undergoing abdominal
myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time
and to describe the injection sequelae for the same population. This clinical study will be
conducted in compliance with the clinical study protocol and applicable regulatory
requirements.
Description:
Fibroids are firm benign tumors that are made of smooth muscle cells and fibrous connective
tissue. Benign uterine leiomyomas (fibroids) are the most common pelvic tumor in women,
affecting 20-40% of all women over the age of 35 and 50% of African American women.
Approximately 20-40% of women with fibroids experience significant symptoms and consult
gynecologic care. However, their true prevalence is probably underestimated . The most common
clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility,
and recurrent pregnancy loss . Less commonly, women with a uterine mass presumed to be a
leiomyoma are found to have a uterine sarcoma or a leiomyoma variant Although hysterectomy is
the definitive treatment for myomas, myomectomy remains the gold-standard treatment for women
wishing to preserve their uterus and fertility . However, bleeding is often a problem in a
myomectomy and can result in intra-operative hypovolaemic shock, post-operative anemia, and
delayed recovery .
Three common causes of increased blood loss during abdominal myomectomy are poor surgical
technique, the complexity of intra-abdominal pathology (such as low corpus, intra-
ligamentous myomas, or obliteration of culde-sac), and the excessive loss of intrauterine
blood during dissection of the myomas .
The current treatments for uterine fibroids are many, medical as progesterone's and
progesterone antagonist's, surgical, and recent myoma therapies as uterine artery
embolization, but surgical resection is still the main treatment, including hysterectomy and
myomectomy. With hysterectomy, uterine fibroids can be completely cured, but it cannot keep
women's reproductive functions. Despite the rate of relapse, myomectomy is still the most
popular surgical treatment for fibroids in women .
A myomectomy excises the fibroid(s) and repairs any defect in the uterine wall, while
preserving the uterus. For this reason, myomectomy is an option for women who desire future
pregnancies or who wish to retain their uterus. After myomectomy, fibroids could recur, which
could lead to subsequent intervention(s) . A laparoscope can be used to remove the fibroid(s)
through small incisions in the abdominal wall (laparoscopic) or a hysteroscope can be used to
reach the fibroid(s) through the cervix (hysteroscopic).
Although laparoscopic myomectomy has been performed since Semm and colleagues described the
procedure in late 1970s , the role of laparoscopic myomectomy as a treatment option for
symptomatic uterine fibroids has been questioned. Many fibroids that can be easily removed
laparoscopically may not require surgical intervention .
Laparoscopic myomectomy was given lukewarm support in the May 2000 American College of
Obstetricians and Gynecologists (ACOG) guidelines : The two major concerns with laparoscopic
myomectomy versus hysterectomy are the removal of large myomas through small abdominal
incisions and the repair of the uterus. The introduction of more efficient morcellators has
made the removal easier, although skilled operative technique is necessary because injury to
other organs is possible .
Although there are multiple techniques available for laparoscopic suturing, there is
controversy as to whether the closure techniques available are equal to those achieved at
laparotomy. This is most relevant to women contemplating a future pregnancy. In spite of
these reservations, recently published studies indicate that laparoscopic myomectomy may be
an appropriate alternative to abdominal myomectomy in well selected patients. Many
reproductive surgeons have the prerequisite skills to perform laparoscopic myomectomy, and
advances in instruments and techniques have made this approach more accessible to physicians
and patients .
Cosmetic consideration and postoperative recovery is always a concern, which results in the
request of minimally invasive procedures . Following the initial application of laparoscopic
myomectomy (LM) in 1979 by Semm , this minimally invasive technique has become more and more
popular worldwide. Conventionally, a three- to four-port wound technique is applied for LM.
The main trocar (10 mm port) is inserted through the umbilicus to introduce the video system
after pneumoperitoneum insufflation with carbon dioxide. Other two- or three-accessory
trocars (5mm port or 10mm port) were inserted into the abdomen over the left lower quadrant,
right lower quadrant, and suprapubic area, for the operative instruments and the suction
irrigator machine .
As hemorrhage is the main complication so, reduction of intra-operative bleeding has become a
major concern. This can be achieved by the use of mechanical or pharmacologic methods, which
can be done pre-operative and intra-operative. Mechanical methods include the use of
tourniquets and clamps that occlude the uterine blood supply to reduce blood loss during
myomectomy. Pharmacologic methods include local Oxytocin injection, vasoconstrictors like
Vasopressin .
Pre-operative uterine artery embolization decreases blood loss during myomectomy, but this
technique is restricted to particular hospital centers and can be complicated . Laparoscopic
uterine artery occlusion has been described as a treatment for symptomatic myomas .
Carbetocin is an Oxytocin derivative exerting effect via the same molecular mechanisms as
Oxytocin. It was first described in 1987 and is a long-acting synthetic analog of Oxytocin,
with agonist action. The clinical and pharmacological properties of Carbetocin are similar to
those of naturally occurring Oxytocin. Its intravenous half-life is 85 to 100 min which is 10
times longer than that of oxytocin. It has a rapid onset and long-lasting action .
Carbetocin and uterine oxytocin receptors in the uterus caused rhythmic contraction, which
can increase the frequency of existing contractions as well as uterine tone. During surgery,
the uterine smooth muscles were made to contract so that the tumor protrudes from the uterine
surface and the level of the tumor cavity would be easy to find and peel . Carbetocin
functions as an agonist at peripheral Oxytocin receptors, particularly in the myometrium,
resulting in rhythmic contractions of the uterus, increased frequency of existing
contractions, and increased uterine tone Terlipressin (triglycyl-lysine vasopressin) became
popular in the early 1990s because it has a prolonged duration of action. It is a prodrug and
is converted to the lysine vasopressin in the circulation after the N-triglycyl residue is
cleaved by endothelial peptidases. This results in a 'slow release' of the vasoactive lysine
vasopressin . The effect half-life of terlipressin is 6hr. It causes a prolonged reduction of
portal venous pressure (mean 103 min) . The elimination half-life of terlipressin is 50 min .
Owing to its pronounced vasoconstrictive effect within the splanchnic circulation,
terlipressin is widely used to treat patients suffering from variceal bleeding during the
treatment of hepatorenal syndrome and catecholamine-unresponsive septic shock. Because
previous studies have shown a reduction of intravasation by vasopressin during hysteroscopy,
we think that its analog, terlipressin, should have the same effect. Terlipressin is an
authorized and licensed product used by many clinicians, and its efficacy is supported by
sufficient published evidence .
Our study aims to evaluate the efficacy of intramyometrial injection of Terlipressin versus
intramyometrial injection of Carbetocin on hemoglobin level in women undergoing abdominal
myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time
and to describe the injection sequelae for the same population. This clinical study will be
conducted in compliance with the clinical study protocol and applicable regulatory
requirements.
