AzTrials
AzTrials

Fibroid UterusNCT02879058

Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

A study testing Intraoperative contact ultrasonography in people with Fibroid Uterus and Quality of Life, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic myomectomy impacts quality of life. Half of participants will undergo laparoscopic or robotic myomectomy with use of the intraoperative ultrasound and half will undergo traditional laparoscopic or robotic myomectomy. Read more about this study

Who is it for?
Ages 21 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibroid Uterus, Quality of Life
What is being tested?
Intraoperative contact ultrasonography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteUnited States
Study dates
Jun 2016to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Premenopausal and nonpregnant
  • Advised to undergo laparoscopic or robotic myomectomy by their provider
  • Documented imaging with transvaginal ultrasound or pelvic MRI within the past year, which accurately and within reason documents the location and number of leiomyomas present within the uterus
  • If deemed necessary by the provider, must have a pelvic MRI prior to surgery that states there are no concerning findings for malignancy
  • Must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy
  • Must understand and voluntarily sign an informed consent form.

Who cannot join

  • Appearance of uterus concerning for malignancy on pelvic MRI
  • Current pregnancy
  • Any contraindication to laparoscopic or robotic surgery
  • Treatment with gonadotropin-releasing hormone (GnRH) analogs in the past 36 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: The Effect of Intraoperative Contact Sonography on Quality of Life Following Laparoscopic or Robotic Myomectomy

This study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic myomectomy impacts quality of life. Half of participants will undergo laparoscopic or robotic myomectomy with use of the intraoperative ultrasound and half will undergo traditional laparoscopic or robotic myomectomy.

Read the detailed description

In full acknowledgement of the correlation between complete leiomyoma exeresis and symptom relief, the investigators hypothesize that use of contact ultrasonography at the time of laparoscopic or robotic myomectomy will enable improved identification and extraction of uterine fibroids which will, in turn, lead to a greater improvement in quality of life among those women who receive intraoperative ultrasound compared to those who do not. In this blinded randomized controlled trial, the investigators will augment traditional laparoscopic and robotic myomectomy with intraoperative ultrasound in half the symptomatic patients enrolled in the study. The other half will be randomized to undergo laparoscopic or robotic myomectomy without use of intra-operative ultrasound. Both groups will complete Uterine Fibroid Symptom and Quality of Life (UFS- QOL) questionnaires before and after surgery (6 months post procedure) to determine whether use of laparoscopic contact ultrasonography has a positive impact on patients' quality of life.

Being tested
Intraoperative contact ultrasonography
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative contact ultrasonographyProcedure or surgery

    In patients randomized to myomectomy with contact ultrasonography, the laparoscopic or robotic ultrasound probe will be advanced through an existing port site into the pelvis after traditional myomectomy has been performed. The face of the ultrasound transducer will be guided over the uterus (including open hysterotomy sites) in systematic strokes, taking special care to note locations of myomas that may have been missed by the preceding excision. Additional hysterotomy sites will be made as necessary in order to remove persistent myomas. Any number of additional ultrasound passes and excisions may be performed in order to achieve the most comprehensive removal of myomas.

Study groups in NCT02879058
Study groupRoleWhat they receive
Without UltrasoundNo interventionLaparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography
With UltrasoundExperimentalLaparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography
Receives: Procedure: Intraoperative contact ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Quality of Life

    Symptom and health-related quality of life will be measured by The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire administered to all study participants before myomectomy and 6 months post-myomectomy.

    Measured: Measured at baseline (before surgery) and 6 months post-surgery

Secondary outcomes (3)

  1. Operating Time

    Operating time is defined as the total period of time from when the procedure starts until the procedure is deemed complete.

    Measured: Measured at surgery

  2. Blood Loss

    Blood loss (in mL) will be estimated for all procedures by the primary surgeon and gleaned from the anesthesia operative flowsheet.

    Measured: Measured at surgery

  3. Weight of Excised Myomas

    After extraction, all myomas will be submitted to pathology. Their cumulative weight will be measured by the Pathologist and gleaned by the research team from the final pathology report.

    Measured: Measured at the time of Pathology evaluation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

Why it stopped: Due to inadequate enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02879058
Sponsor's protocol ID
FLA- 16-031
Status last verified
Feb 2019
First submitted
25 Jul 2016
Last updated
4 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Selected de-identified ultrasound images and surgical data will be shared with BK Ultrasound, the manufacturer of the ultrasound device.

Publications

  • Shimanuki H, Takeuchi H, Kikuchi I, Kumakiri J, Kinoshita K. Effectiveness of intraoperative ultrasound in reducing recurrent fibroids during laparoscopic myomectomy. J Reprod Med. 2006 Sep;51(9):683-8.

    PubMed 17039695

  • Nezhat FR, Roemisch M, Nezhat CH, Seidman DS, Nezhat CR. Recurrence rate after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc. 1998 Aug;5(3):237-40. doi: 10.1016/s1074-3804(98)80025-x.

    PubMed 9668143

  • Mais V, Ajossa S, Guerriero S, Mascia M, Solla E, Melis GB. Laparoscopic versus abdominal myomectomy: a prospective, randomized trial to evaluate benefits in early outcome. Am J Obstet Gynecol. 1996 Feb;174(2):654-8. doi: 10.1016/s0002-9378(96)70445-3.

    PubMed 8623802

  • Radosa MP, Owsianowski Z, Mothes A, Weisheit A, Vorwergk J, Asskaryar FA, Camara O, Bernardi TS, Runnebaum IB. Long-term risk of fibroid recurrence after laparoscopic myomectomy. Eur J Obstet Gynecol Reprod Biol. 2014 Sep;180:35-9. doi: 10.1016/j.ejogrb.2014.05.029. Epub 2014 Jun 2.

    PubMed 25016181

  • Fedele L, Parazzini F, Luchini L, Mezzopane R, Tozzi L, Villa L. Recurrence of fibroids after myomectomy: a transvaginal ultrasonographic study. Hum Reprod. 1995 Jul;10(7):1795-6. doi: 10.1093/oxfordjournals.humrep.a136176.

    PubMed 8582982

  • Hanafi M. Predictors of leiomyoma recurrence after myomectomy. Obstet Gynecol. 2005 Apr;105(4):877-81. doi: 10.1097/01.AOG.0000156298.74317.62.

    PubMed 15802421

  • Fauconnier A, Chapron C, Babaki-Fard K, Dubuisson JB. Recurrence of leiomyomata after myomectomy. Hum Reprod Update. 2000 Nov-Dec;6(6):595-602. doi: 10.1093/humupd/6.6.595.

    PubMed 11129693

  • Doridot V, Dubuisson JB, Chapron C, Fauconnier A, Babaki-Fard K. Recurrence of leiomyomata after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc. 2001 Nov;8(4):495-500. doi: 10.1016/s1074-3804(05)60610-x.

    PubMed 11677326

  • Piccolboni P, Settembre A, Angelini P, Esposito F, Palladino S, Corcione F. Laparoscopic ultrasound: a surgical "must" for second line intra-operative evaluation of pancreatic cancer resectability. G Chir. 2015 Jan-Feb;36(1):5-8.

    PubMed 25827662

  • Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

    PubMed 11814511

  • Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012 Jun;35(3):530-6. doi: 10.1007/s00270-011-0228-5. Epub 2011 Jul 20.

    PubMed 21773858

  • Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.

    PubMed 12719681

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative contact ultrasonography in people with Fibroid Uterus and Quality of Life, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to inadequate enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of Life (time frame: Measured at baseline (before surgery) and 6 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02879058, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in