Clinical trial · Interventional
Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients
The Effect of Intraoperative Contact Sonography on Quality of Life Following Laparoscopic or Robotic Myomectomy
NCT02879058CI-TRIAL-00037411terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to inadequate enrollment.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative contact ultrasonography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Without Ultrasound
- description
- Laparoscopic or robotic myomectomy will be performed without aid of intraoperative contact ultrasonography
- type
- EXPERIMENTAL
- label
- With Ultrasound
- description
- Laparoscopic or robotic myomectomy will be performed with aid of intraoperative contact ultrasonography
- interventionNames
- Procedure: Intraoperative contact ultrasonography
Primary outcomes (1)
- measure
- Change in Quality of Life
- timeFrame
- Measured at baseline (before surgery) and 6 months post-surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Premenopausal and nonpregnant 2. Advised to undergo laparoscopic or robotic myomectomy by their provider 3. 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 4. If deemed necessary by the provider, must have a pelvic MRI prior to surgery that states there are no concerning findings for malignancy 5. Must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy 6. Must understand and voluntarily sign an informed consent form. Exclusion Criteria: 1. Appearance of uterus concerning for malignancy on pelvic MRI 2. Current pregnancy 3. Any contraindication to laparoscopic or robotic surgery 4. Treatment with gonadotropin-releasing hormone (GnRH) analogs in the past 36 months
References
Publications (12)
- BACKGROUNDShimanuki 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
- BACKGROUNDNezhat 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
- BACKGROUNDMais 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
- BACKGROUNDRadosa 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
- BACKGROUNDFedele 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
- BACKGROUNDHanafi 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
- BACKGROUNDFauconnier 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
- BACKGROUNDDoridot 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.