What side effects are associated with this type of intervention?

The most common treatments for fibroids, such as abdominal myomectomy and hysterectomy, can have several side effects. Abdominal myomectomy may lead to significant blood loss, infection, and longer recovery times. Hysterectomy, while definitive, carries risks of surgical complications, hormonal changes, and longer hospital stays. Laparoscopic procedures involving morcellation, although minimally invasive, have raised concerns about the potential spread of undiagnosed uterine malignancies, leading to worsened prognosis. Additionally, general risks for all surgical procedures include anesthesia-related complications, pain, and adhesions.

What prior FDA approvals exist?

The FDA has approved various treatments for uterine fibroids, including medications and surgical procedures. Medications such as gonadotropin-releasing hormone (GnRH) agonists are commonly used to shrink fibroids before surgery. In terms of surgical approaches, the FDA has issued safety alerts regarding the use of power morcellators due to the risk of spreading undiagnosed cancerous tissues. Contained morcellation techniques have been developed to mitigate this risk by using specialized bags to contain and remove fibroid tissue during laparoscopic surgery. These advancements aim to improve the safety and outcomes of minimally invasive fibroid removal procedures.

What other types of research exist?

Promising novel alternatives to contained morcellation for fibroid treatment include robot-assisted laparoscopic myomectomy, which offers advantages like easier suturing and reduced blood loss, and hysteroscopic myomectomy, which is effective for submucosal fibroids. Both methods provide less invasive options with faster recovery times compared to traditional open surgery.

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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

Must not have

Contraindications to laparoscopy

Conversion to laparotomy or inability to complete morcellation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods of removing the uterus during minimally invasive hysterectomy surgeries. One method uses the abdomen, and the other uses the vagina. The study aims to find out which method leads to better surgical and recovery outcomes for patients.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have laparoscopy due to health reasons.

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My surgery was changed to an open procedure or couldn't complete tissue removal.

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I do not have chronic pain that needs ongoing treatment, except for endometriosis.

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I have a pre-cancerous condition or a known gynecologic cancer.

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I am scheduled for a hysterectomy through my abdomen or vagina.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean difference in total operating room time

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~820

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for fibroids include surgical options such as myomectomy and hysterectomy, often involving morcellation. Morcellation is a technique where large fibroids are divided into smaller pieces to facilitate removal through minimally invasive procedures like laparoscopy. This method reduces recovery time and surgical risks compared to open surgery. However, it carries a risk of spreading undiagnosed malignant cells, such as uterine sarcomas, within the abdominal cavity. Understanding these mechanisms is crucial for fibroid patients as it helps them weigh the benefits of minimally invasive surgery against the potential risks of cancer dissemination, enabling informed decision-making with their healthcare providers.

Pregnancy outcomes following robot-assisted myomectomy.Traditional surgical approaches to uterine fibroids: abdominal myomectomy and hysterectomy.