Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients

NCT02879058 | Terminated DMC

• 1 other identifier: FLA- 16-031
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroid Uterus; Quality of Life

Outcome Measures

Primary Outcomes (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 at baseline (before surgery) and 6 months post-surgery

Secondary Outcomes (3)

• Operating Time

  Measured at surgery

• Blood Loss

  Measured at surgery

• Weight of Excised Myomas

  Measured at the time of Pathology evaluation.

Study Arms (2)

Without Ultrasound

NO INTERVENTION

Laparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography

With Ultrasound

EXPERIMENTAL

Laparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography

Procedure: Intraoperative contact ultrasonography

Interventions

Intraoperative contact ultrasonography PROCEDURE

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.

With Ultrasound

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (12)

• 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.

  PMID: 17039695 BACKGROUND

• 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.

  PMID: 9668143 BACKGROUND

• 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.

  PMID: 8623802 BACKGROUND

• 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.

  PMID: 25016181 BACKGROUND

• 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.

  PMID: 8582982 BACKGROUND

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

  PMID: 15802421 BACKGROUND

• 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.

  PMID: 11129693 BACKGROUND

• 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.

  PMID: 11677326 BACKGROUND

• 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.

  PMID: 25827662 BACKGROUND

• 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.

  PMID: 11814511 BACKGROUND

• 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.

  PMID: 21773858 BACKGROUND

• 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.

  PMID: 12719681 BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Stephen E Zimberg, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

• Katherine A Smith, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical fellow

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 25, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)