Laparoscopy Clinical Trial
Official title:
A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy
Verified date | January 2024 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy. Exclusion Criteria: 1. History of adverse reaction or allergy to Vasopressin. 2. History of adverse reaction or allergy to Misoprostol. 3. Medical contraindication to use of Vasopressin or Misoprostol 4. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue. 5. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating. 6. Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course. 7. Pregnant women |
Country | Name | City | State |
---|---|---|---|
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Antonios Likourezos |
United States,
Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4. — View Citation
Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124 — View Citation
Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4. — View Citation
Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9. — View Citation
Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin Levels Difference Between Pre and Post Surgery. | The difference in hemoglobin levels between pre surgery and post surgery | 1 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04515485 -
A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
|
||
Completed |
NCT01725477 -
Laparoscopic Tubal Patency Assessment
|
N/A | |
Recruiting |
NCT01093430 -
Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?
|
N/A | |
Recruiting |
NCT01093079 -
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
|
N/A | |
Completed |
NCT01092013 -
Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices
|
N/A | |
Completed |
NCT00535990 -
Minimally Invasive Surgery (MIS) Database for the Purpose of Research
|
||
Recruiting |
NCT06044909 -
Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
|
||
Completed |
NCT06255080 -
Comparing Skills Acquisition on Different Laparoscopy Software
|
N/A | |
Not yet recruiting |
NCT05389241 -
Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial
|
N/A | |
Enrolling by invitation |
NCT03234543 -
Remote Ischemic Conditioning in Abdominal Surgery
|
N/A | |
Recruiting |
NCT02827292 -
Effect of Music on Inflammatory Response During Laparoscopic Surgery
|
N/A | |
Not yet recruiting |
NCT06092684 -
The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery
|
Phase 3 | |
Terminated |
NCT01008709 -
Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery
|
N/A | |
Active, not recruiting |
NCT05363813 -
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
|
N/A | |
Completed |
NCT03330236 -
EEG - Guided Anesthetic Care and Postoperative Delirium
|
N/A | |
Recruiting |
NCT05031182 -
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
|
N/A | |
Active, not recruiting |
NCT05302622 -
Detecting the Most Efficient Residency Time for Laparoscopic Simulators
|
N/A | |
Recruiting |
NCT03684291 -
Hemodynamic Effects of Ventilation Modes
|
||
Recruiting |
NCT06117748 -
Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery
|
N/A | |
Recruiting |
NCT03739944 -
Different Surgical Approaches in Patients of Early-stage Cervical Cancer
|
Phase 3 |