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Procedure

Laparoscopic Hysterectomy Techniques for Fibroids

N/A

Waitlist Available

Led By Kimberly A Kho, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years old

Adnexectomy, cystectomy, tubal procedures at time of hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

Study Summary

This trial is testing whether there are differences in outcomes between two types of surgery for hysterectomies.

Who is the study for?

This trial is for women over 18 needing a hysterectomy due to benign conditions, with a uterus size over 12 weeks or heavier than 250 grams. Candidates must be English or Spanish speakers and can have additional procedures like oophorectomy at the time of surgery. Women with planned other surgeries, contraindications to laparoscopy, pre-malignant/malignant gynecologic conditions, or chronic pain disorders are excluded.Check my eligibility

What is being tested?

The study compares two methods of removing the uterus in laparoscopic hysterectomies: abdominal morcellation (AM) and vaginal morcellation (VM). It's designed as a randomized controlled trial to see which method has better surgical outcomes and recovery experiences for patients.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with laparoscopic surgery such as infection, bleeding, damage to surrounding organs/tissues, and complications related to anesthesia. Specific side effects from AM versus VM will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have had surgery to remove ovaries or fallopian tubes at the time of my hysterectomy.

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My uterus is larger than usual, as confirmed by tests.

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I have had a hysterectomy using laparoscopy or robotics, with or without ovary removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 6-weeks post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 6-weeks post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 6-weeks post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean difference in total operating room time

Secondary outcome measures

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

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vaginal MorcellationExperimental Treatment1 Intervention

Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.

Group II: Abdominal MorcellationExperimental Treatment1 Intervention

Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Total Laparoscopic Hysterectomy

2005

Completed Phase 3

~770

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,753 Total Patients Enrolled

Kimberly A Kho, MDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

Journal of Minimally Invasive GynecologyJournal

Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy

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.

Journal of Minimally Invasive GynecologyJournal

Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity

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.

American Journal of Obstetrics and GynecologyJournal

Transumbilical Versus Transvaginal Retrieval of Surgical Specimens at Laparoscopy: A Randomized Trial

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.

Obstetrics & GynecologyJournal