Study Summary
This trial is testing whether there are differences in outcomes between two types of surgery for hysterectomies.
Eligible Conditions
- Fibroid Uterus
- Abnormal Uterine Bleeding
- Surgery
- Uterine Bleeding
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: intraoperative
after surgery to 2-weeks post-operatively
Abdomen
intraoperative
Mean difference in total operating room time
Morcellation Time
through study completion up to 6-weeks post-operatively
Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
Pain
Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
Rates of Post-Operative Complications
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Abdominal Morcellation
1 of 2
Vaginal Morcellation
1 of 2
Experimental Treatment
46 Total Participants · 2 Treatment Groups
Primary Treatment: Total Laparoscopic Hysterectomy · No Placebo Group · N/A
Abdominal Morcellation
Procedure
Experimental Group · 1 Intervention: Total Laparoscopic Hysterectomy · Intervention Types: ProcedureVaginal Morcellation
Procedure
Experimental Group · 1 Intervention: Total Laparoscopic Hysterectomy · Intervention Types: ProcedureTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Laparoscopic Hysterectomy
2005
Completed Phase 3
~760
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
962 Previous Clinical Trials
1,108,441 Total Patients Enrolled
Kimberly A Kho, MDPrincipal InvestigatorUT Southwestern Medical Center
Eligibility Criteria
Age 18 - 50 · Female Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be able to speak English or Spanish.
References
- Meurs, Elsemieke A.I.M., Luiz Gustavo Brito, Mobolaji O. Ajao, Emily R. Goggins, Allison F. Vitonis, Jon I. Einarsson, and Sarah L. Cohen. 2017. “Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy”. Journal of Minimally Invasive Gynecology. Elsevier BV. doi:10.1016/j.jmig.2017.04.023.
- Solima, Eugenio, Giuseppe Scagnelli, Veronica Austoni, Andrea Natale, Carlo Bertulessi, Mauro Busacca, and Michele Vignali. 2015. “Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity”. Journal of Minimally Invasive Gynecology. Elsevier BV. doi:10.1016/j.jmig.2015.07.007.
- Ghezzi, Fabio, Antonella Cromi, Stefano Uccella, Giorgio Bogani, Maurizio Serati, and Pierfrancesco Bolis. 2012. “Transumbilical Versus Transvaginal Retrieval of Surgical Specimens at Laparoscopy: A Randomized Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2012.05.016.
- Siedhoff, Matthew T., and Sarah L. Cohen. 2017. “Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002334.
- Cohen, Sarah L., Jon I. Einarsson, Karen C. Wang, Douglas Brown, David Boruta, Stacey A. Scheib, Amanda N. Fader, and Tony Shibley. 2014. “Contained Power Morcellation Within an Insufflated Isolation Bag”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000000421.
- Frascà, Clarissa, Eugenia Degli Esposti, Alessandro Arena, Gianmarco Tuzzato, Elisa Moro, Valentina Martelli, and Renato Seracchioli. 2017. “Can In-bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial”. Gynecologic and Obstetric Investigation. S. Karger AG. doi:10.1159/000477171.
- Cohen, Sarah L., Nisse V. Clark, Mobolaji O. Ajao, Douglas N. Brown, Antonio R. Gargiulo, Xiangmei Gu, and Jon I. Einarsson. 2019. “Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy Versus Vaginal Approach”. Journal of Minimally Invasive Gynecology. Elsevier BV. doi:10.1016/j.jmig.2018.07.020.
- Moawad, Gaby N., Elias D. Abi Khalil, Jessica Opoku-Anane, Cherie Q. Marfori, Alice C. Harman, Steven Fisher, Matt Levy, and James K. Robinson. 2015. “Comparison of Methods of Morcellation: Manual Versus Power”. Acta Obstetricia Et Gynecologica Scandinavica. Wiley. doi:10.1111/aogs.12783.
- Venturella, Roberta, Morena L. Rocca, Daniela Lico, Nicolò La Ferrera, Roberto Cirillo, Salvatore Gizzo, Michele Morelli, Errico Zupi, and Fulvio Zullo. 2016. “In-bag Manual Versus Uncontained Power Morcellation for Laparoscopic Myomectomy: Randomized Controlled Trial”. Fertility and Sterility. Elsevier BV. doi:10.1016/j.fertnstert.2015.12.133.
- US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
- US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
- Venturella, Roberta, Morena L. Rocca, Daniela Lico, Nicolò La Ferrera, Roberto Cirillo, Salvatore Gizzo, Michele Morelli, Errico Zupi, and Fulvio Zullo. 2016. “In-bag Manual Versus Uncontained Power Morcellation for Laparoscopic Myomectomy: Randomized Controlled Trial”. Fertility and Sterility. Elsevier BV. doi:10.1016/j.fertnstert.2015.12.133.
- Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.
- Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.
- Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.
- Kimberly Kho 2020. "Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04434066.
Frequently Asked Questions
What characteristics make a person eligible to be involved in this trial?
"Patients wishing to participate must present with vaginal bleeding and be within the age bracket of 18-50. 36 individuals are expected to enroll in this trial." - Anonymous Online Contributor
Unverified Answer
Are senior citizens eligible as participants in this research project?
"In order to join this clinical trial, all participants must be between 18 and 50 years of age. Comparatively, there are 87 trials specifically targeting patients under the age of 18 and 539 which accept people over 65." - Anonymous Online Contributor
Unverified Answer
What is the aggregate number of volunteers taking part in this clinical experiment?
"Affirmative, clinicaltrials.gov data suggests this clinical trial is enrolling participants at the present time. The investigation was initially advertised on August 1st 2020 and most recently updated on July 27th 2022; 36 individuals need to be recruited from one site in particular." - Anonymous Online Contributor
Unverified Answer
Are there vacancies available for the clinical trial?
"Affirmative. According to clinicaltrials.gov, this experiment has been open for recruitment since the 8th of January 2020 and was last updated on the 27th July 2022. It is currently searching for 36 participants from one medical facility." - Anonymous Online Contributor
Unverified Answer