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Vasopressins

Arginine Vasopressin

Misoprostol

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Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .

20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Standard

20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Standard-vaginal misoprostol

Pedram Bral, M.D.

Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.

Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.

Combined Vaginal Misoprostol and Perivascular Vasopressin

A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy

The difference in hemoglobin levels between pre surgery and post surgery

Antonios Likourezos

Research Administration Director

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.

Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .

Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Standard-Vaginal Misoprostol

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Pedram Bral, MD

Hemoglobin Levels Difference Between Pre and Post Surgery.

Overall Study

Neoplasms, Connective Tissue

Connective Tissue Diseases

Pharmaceutical Solutions

Amino Acids

Hemostatics

Arginine

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.

During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.

Vasopressin

Hee Seung Kim, MD/PhD

The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.

This study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy. We would like to evaluate the feasibility and validity of this study for future Phase III randomized clinical trials through this preliminary randomized assignment study.

Uterine fibroids are the most common tumors in women, and uterine myomectomy, which is performed as a treatment for them, is basically a high risk of bleeding and blood transfusion. A common method to reduce intraoperative bleeding is to inject diluted vasopressin into the subserosal areas of the fibroids. However, no proper level of vasopressin dilution has been determined so far, so we want to determine an effective dilution concentration of vasopressin that can minimize side effects through this clinical trial.

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study

The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle

Time from anesthesia start to delivery of patient to recovery room

Whether patients are transfused during admission period Number of units transfused red blood cell

The amount of fluid injected during operation

CHA University

Seoul National University Hospital

Associate Professor

Myoma

Adenomyoma

Gynecological laparoscopic surgery with augmented reality device.

Laparoscopic surgery with augmented reality device

Lise LACLAUTRE

Olivier DONNEZ

Pauline CHAUVET

Céline CHAULEUR

Augmented Reality is a technology that allows surgeons to superimpose virtual images from preoperative imaging onto the endoscopic vision system intraoperatively. The goal of this clinical trial is to demonstrate that the use of augmented reality during laparoscopic gynecological surgery with a dedicated device could provide assistance to the surgeon, in terms of technical comfort and better visualization of the benign tumor to be resected on a mobile organ.

Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)

Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures.

The feasibility of the technique will be considered satisfactory if the SURG-TLX score given by the surgeon at the end of the procedure is less than or equal to 33.7 (threshold defined by experts).

Measuring the performance-related score when using the augmented reality device by filling in a scale.

Collection of operating times for the entire surgery, as well as the various times associated with augmented reality device installation.

Number of device failures during surgery (defined as an abrupt stop of the device during its use)

Collection of the number of failures to set up the augmented reality device

Collection of the real direct medical costs of the procedure from an institutional point of view.

Collection of the number of laparoscopic/laparotomy conversions.

Collection of the number of intraoperative and postoperative complications (especially vascular or ureteral wounds).

Collection of bleeding volume during the surgery.

University Hospital, Clermont-Ferrand

Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.

Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary.

triple tourniquet

Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.

Single tourniquet

The aim of study is to compare triple tourniquet vs. single tourniquet to reduce blood loss at open myomectomy.

Single tourniquet is applied to uterine isthmus to occlude uterine arteries. Triple tourniquet is applied to both infundibulopelvic ligaments and uterine isthmus.

Uterine Tourniquet at Open Myomectomy

Triple Tourniquet vs. Single Tourniquet at Open Myomectomy to Reduce Blood Loss: A Prospective Randomised Controlled Trials

Including but not limited to fever, pelvic infections, wound infections.

Surgical blood loss will be estimated by sum of the volume of suction fluid and blood loss quantitated by gravimetric method.

During surgery, if it is possible, irrigation will not be done, surgical sponge and compress will not be used.

* Suction fluid will be measured at the end of operation and volume of irrigation fluid will be subtracted from total suction volume.
* Surgical drapes, sponges and towels will be weighted before and just after surgery. The blood loss will be estimated as differences in gram by weighing when 1ml blood supposed as 1 gr.

Erythrocyte transfusions transfusion will be allowed when haemoglobin dropped below 8 g/dL.

Drain will be removed when discharge drops below 50 ml/day

Anti-Mullerian Hormone levels before and 6 months after surgery

Erzurum Nenehatun Kadın Doğum Hastanesi

Ataturk University

Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures

E-NOTES

Myong Cheol Lim, MD, PhD

Primary objectives : To investigate technical feasibility and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures

Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with Traction of Multidirectional Sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.

* Leiomyoma is a common benign tumor of the smooth muscle cells of the myometrium.1 It can cause several symptoms such as abnormal vaginal bleeding, pain, or urinary symptoms according to size and location. Steadily, lesser invasive surgeries have been preferred for such benign disease (laparotomy, laparoscopy, and then single-port surgery).2,3
* However, these minimal approaches, laparoscopic morcellation of preoperatively suspicious leimyoma, have the potential risk of peritoneal seeding of postoperative diagnosed leiomyosarcoma in the pathological examination.4 Currently, safe morcellation is also required during myomectomy while using a lesser invasive surgical approach such as single-port surgery or natural orifice transumbilical endoscopic surgery (NOTES).
* During single-port surgery or embryonic NOTES (E-NOTES) via an umbilicus, handling of myoma into different directions could be quite a big challenge. Fortunately, myoma is enough hard to pull with string and has a tendency not to rupture during manipulation of these strings.
* These concepts lead to traction of anchoring sutures during E-NOTES for myomectomy applied in the current case. Safe morcellation could be guaranteed, because direction morcellation via an umbilicus is possible in an endobag.
* This useful and safe surgical approach needs to be confirmed in multi-centers in terms of feasibility and morbidity.

Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures

Multi-center Prospective Study on Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy With Traction of Multidirectional Sutures

Technical feasibility and postoperative morbidity will be evaluated in terms of overall or institutional conversion rate to convetional multi-port laparoscopy or laparotomy, operation time for each surgical procedures: dissection, morecellation, suturing, and total surgical procedures, complication, change of hemoglobin, and estimated blood loss

Visual analogue scale will be used for pain evaluation: preoperative, postoperative 24 hour, postoperative 48 hour, postoperative 10 day (7 to 10 day), and postoperative 28 day (21 to 35 day).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Vaginal Misoprostol and Perivascular Vasopressin	NCT03815344	Leiomyoma Laparoscopy Uterine Myomect...	Standard Standard-vagina...	18 Years - 55 Years	Maimonides Medical Center
Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy	NCT04874246	Uterine Leiomyo...	Vasopressin	19 Years - 60 Years	Seoul National University Hospital
Combined Vaginal Misoprostol and Perivascular Vasopressin	NCT03815344	Leiomyoma Laparoscopy Uterine Myomect...	Standard Standard-vagina...	18 Years - 55 Years	Maimonides Medical Center
Evaluation of the Feasibility of Using Augmented Reality in Laparoscopic Surgery, by a Clinical Study During Gynecological Laparoscopic Surgical Procedures. (ENDORA2)	NCT06067971	Myoma;Uterus Adenomyoma of U...	Laparoscopic su...	18 Years - 84 Years	University Hospital, Clermont-Ferrand
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University
Uterine Tourniquet at Open Myomectomy	NCT02049242	Myomectomy Uterine Leiomyo...	triple tourniqu... Single tourniqu...	16 Years - 48 Years	Ataturk University
Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures	NCT01829022	Myoma	E-NOTES	20 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for uterine myomectomy