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Neoplasms, Connective Tissue

Connective Tissue Diseases

Women undergoing uterine myomectomy by open surgery (laparotomy).

Women undergoing uterine myomectomy by laparoscopy.

Women undergoing uterine myomectomy by robotic surgery.

Diagnostic hysteroscopy performed in outpatient setting, using "no touch" vaginoscopy technique with a 2.9 mm 30-degree rigid hysteroscope with a single inflow sheet using normal saline as distention media.

Diagnostic hysteroscopy

Antonio Simone Laganà, M.D.

Jose Carugno

Andrea Tinelli

Antonio Simone Laganà

Uterine fibroids are the most common benign tumors of the genital organs of women of childbearing age. Literature data show that more than 75% of women have fibroids.Symptomatic fibroids account for approximately over 200,000 hysterectomies and 50,000 myomectomies annually in the United States. Fibroids have a major impact on fertility, with significant adverse effect on implantation rate and spontaneous abortion rates when compared with infertile women without fibroids. The definitive treatment for uterine fibroids in a fertile patient is surgical excision. Although usually effective, myomectomy is not a risk-free operation, since the surgical procedure can cause mechanical infertility and can be associated with infection, injury to adjacent tissues, hemorrhage and need to convert to hysterectomy. A not often mentioned consequence of myomectomy is post-operative intrauterine adhesion formation. It has been reported that 50% of women undergoing open myomectomy are found to have intrauterine adhesions diagnosed by hysteroscopy performed 3 months after surgery. Such a high prevalence of intrauterine adhesions after open myomectomy is unexpected, however only few studies have addressed this topic.

It is accepted that injury to the endometrium is generally considered to be the primary causative factor for the development of intrauterine adhesions. The reason for such a high incidence of intrauterine adhesions after open myomectomy is unclear. It is speculated that infection or in adverted closure of the uterine cavity may play a role in intrauterine adhesion formation. The relationship between the number of fibroids removed and the risk of adhesions suggests a traumatic etiology. In the preservation of the uterus for the purpose of fertility, it is essential to also understand the impact of myomectomy on the endometrium. Currently no guideline recommends in office hysteroscopy as follow-up after myomectomy. The purpose of the present study is to evaluate the frequency of uterine adhesions following myomectomy and the impact of number, size and location of the fibroids as well as intraoperative breach of the endometrial cavity at the time of the myomectomy.

Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

Presence of intrauterine adhesion, following the American Fertility Society classification (Fertil Steril. 1988;49:944-955.) in mild, moderate, or severe.

University of Miami

Università degli Studi dell'Insubria

Principal Investigator

Central Nervous System Depressants

All Drugs and Chemicals

Bupivacaine

Anesthetics

Anesthetics, Local

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Bupivacaine liposome

normal saline

Daniel Katz, MD

James Leader

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap

The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial

Total cumulative opiates consumed converted to morphine equivalents

Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale.

Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit.

15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.

Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevalence of Intrauterine Adhesions After Abdominal Myomectomy	NCT04030273	Myoma;Uterus	Diagnostic hyst...	18 Years - 45 Years	Università degli Studi dell'Insubria
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy	NCT04272086	Fibroid Uterus	Bupivacaine Bupivacaine lip... normal saline	18 Years - 64 Years	Icahn School of Medicine at Mount Sinai
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy	NCT04272086	Fibroid Uterus	Bupivacaine Bupivacaine lip... normal saline	18 Years - 64 Years	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for abdominal myomectomy