Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Hemorrhage

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Coagulants

All Drugs and Chemicals

Pharmaceutical Solutions

Natriuretic Agents

Tranexamic Acid

Deamino Arginine Vasopressin

Antifibrinolytic Agents

Hemostatics

In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Tranexamic acid

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Saline

Mete Gungor

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.

Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial

Study protocol, statistical analysis might be shared when the study is completed upon request.

The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount.

Preoperative and postoperative hemoglobin values will be recorded.

Patients who received postoperative blood transfusions will be recorded.

Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.

Acibadem University

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Postoperative Complications

Infertility

Pregnancy Complications

Blood Loss, Surgical

Myoma

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Intraoperative Complications

Genital Diseases

Laparoscopic myomectomy is performed with prior visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.

Laparoscopic myomectomy is performed without prior temporary blood supply occlusion.

Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.

Laparoscopic myomectomy with prior temporary uterine blood supply occlusion

Laparoscopic myomectomy without prior temporary uterine blood supply occlusion

Conventional laparoscopic myomectomy

Andrei Dubinin, MD, PhD

Pavel Sorokin, MD

A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.

Primary endpoints

• Assess the volume of blood loss

Secondary endpoints

* Compare the rates of intra- and postoperative complications, the necessity of blood transfusion, length of surgery, length of hospital and ICU stay, and leiomyoma symptoms relief
* Determine the procedure impact on fertility by evaluating the level of anti-mullerian hormone, pregnancy rates, pregnancy complications, and the way of delivery

Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.

Sixty patients will undergo laparoscopic myomectomy preceded by temporary uterine blood supply occlusion performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study. Sixty patients will undergo conventional laparoscopic myomectomy performed by gynecologists at Mother and Child Clinic Saint-Petersburg and other institutions participating in the study.

Patients eligible for inclusion, after signing an informed voluntary consent to participate in the study, will be randomized in a 1:1 ratio to the treatment groups using stratification by age, size, and leiomyoma nodes location.

Patients who meet study inclusion criteria will be randomized into one of two treatment arms: 1) laparoscopic myomectomy preceded by temporary uterine blood supply occlusion or 2) laparoscopic myomectomy with a conventional approach.

ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

ABSOLUTELY: A Multicenter Randomized Controlled Trial of Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

Rates of intra- and postoperative complications, necessity of blood transfusion, length of surgery, length of hospital and ICU stay, leiomyoma symptoms relief

Level of anti-mullerian hormone, rate of pregnancy, pregnancy complications, the way of delivery

Mother and Child Clinic Saint-Petersburg

Gynecologist

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.

Laparoscopic myomectomy with unidirectional barbed suture

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.

Traditional suture material

Jamie Kroft, MD, FRCSC

Grace Y Liu, MD, FRCSC

The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.

Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial

We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.

We will subtract the amount of irrigation fluid used from the total amount of fluid suctioned during the procedure to arrive at an estimated blood loss in millilitres. We will also measure the patient's hemoglobin at the routine pre-operative visit and then on the morning of the first post-operative day to determine the difference in hemoglobin. The amount of intravenous fluids administered to the patients intra- and post-operatively will be documented in order to account for any changes in hemoglobin that are spurious due to fluid administration.

All adverse events that occur until 6 weeks post-operatively will be documented including injury to the bladder, bowel, ureter or blood vessel, infection/abscess, fever, blood transfusion, readmission to hospital, re-operation, and venous thromboembolism.

We will document the length of hospital stay post-operatively in days.

Telephone interviews will be conducted at 2 and 5 years post-operatively to determine pregnancy rates, live birth rates and adverse pregnancy outcomes of participants.

Sunnybrook Health Sciences Centre

Micronutrients

Vitamins

Ascorbic Acid

Antioxidants

Protective Agents

Trace Elements

Vitamin C

ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation

Normal saline 500ml IV infusion for 2hour

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

ascorbic acid

Normal saline

kiding kim, M.D.

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.

Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy

postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.	NCT05517590	Leiomyoma, Uter... Intraoperative ...	Tranexamic acid Saline	18 Years - 60 Years	Acibadem University
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	NCT04519593	Uterine Leiomyo... Uterine Fibroid Leiomyoma, Uter... Myoma;Uterus Laparoscopic My... Postoperative C... Blood Loss, Sur... Fertility Issue... Pregnancy Compl...	Laparoscopic my... Conventional la...	18 Years -	Mother and Child Clinic Saint-Petersburg
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.	NCT05517590	Leiomyoma, Uter... Intraoperative ...	Tranexamic acid Saline	18 Years - 60 Years	Acibadem University
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy	NCT01347385	Fibroids	Laparoscopic my... Traditional sut...	-	Sunnybrook Health Sciences Centre
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy	NCT01347385	Fibroids	Laparoscopic my... Traditional sut...	-	Sunnybrook Health Sciences Centre
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma	NCT01715597	Uterine Leiomyo...	ascorbic acid Normal saline	-	Seoul National University Hospital
ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma	NCT04519593	Uterine Leiomyo... Uterine Fibroid Leiomyoma, Uter... Myoma;Uterus Laparoscopic My... Postoperative C... Blood Loss, Sur... Fertility Issue... Pregnancy Compl...	Laparoscopic my... Conventional la...	18 Years -	Mother and Child Clinic Saint-Petersburg

Spots Global Cancer Trial Database for laparoscopic myomectomy