The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
NCT ID: NCT05811286
Last Updated: 2023-07-14
Study Results
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Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2021-05-20
2023-06-28
Brief Summary
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Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection.
No significant differences in odds of surgical complications have been reported.
Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed.
Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia.
At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation.
Trial objectives:
Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation.
Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions
Single experimental arm of patients with a intracavitary lesion and elligible for hysteroscopic morcellation.
Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions
With the shaver, the lesion is removed in the OR. We will include endometrial polyps, FIGO 0-1 myomas and retained products of conception.
We will assess the completeness of hysteroscopic resection, operation time, need for cervical dilation, adverse events, pain, operator satisfaction; quality of tissue for histological examination, postoperative complications and pain.
Interventions
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Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions
With the shaver, the lesion is removed in the OR. We will include endometrial polyps, FIGO 0-1 myomas and retained products of conception.
We will assess the completeness of hysteroscopic resection, operation time, need for cervical dilation, adverse events, pain, operator satisfaction; quality of tissue for histological examination, postoperative complications and pain.
Eligibility Criteria
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Inclusion Criteria
* Female
Ultrasonographic diagnosis of an intracavitary lesion, according the IETA terms and definitions
* endometrial polyp
* FIGO 0-1 myoma (maximum diameter 2 cm)
* RPOC (maximum diameter 2 cm, no enhanced myometrial vascularity)
Exclusion Criteria
* (possible) malignancy
* \< 18y
* Patient refusal
* Pregnancy
* Impossibility to access the uterine cavity (e.g. severe cervical stenosis)
* Absence of intracavitary lesion (endometrial polyp, FIGO 0-1 myoma or RPOC) at hysteroscopy
18 Years
FEMALE
No
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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Ziekenhuis Oost-Limburg
Genk, , Belgium
University Hospitals Leuven
Leuven, , Belgium
Countries
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References
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Munro MG, Christianson LA. Complications of Hysteroscopic and Uterine Resectoscopic Surgery. Clin Obstet Gynecol. 2015 Dec;58(4):765-97. doi: 10.1097/GRF.0000000000000146.
Shazly SA, Laughlin-Tommaso SK, Breitkopf DM, Hopkins MR, Burnett TL, Green IC, Farrell AM, Murad MH, Famuyide AO. Hysteroscopic Morcellation Versus Resection for the Treatment of Uterine Cavitary Lesions: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):867-77. doi: 10.1016/j.jmig.2016.04.013. Epub 2016 May 7.
Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016 Feb;22(1):56-61. doi: 10.12809/hkmj154600. Epub 2016 Jan 8.
Haber K, Hawkins E, Levie M, Chudnoff S. Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database. J Minim Invasive Gynecol. 2015 Jan;22(1):110-4. doi: 10.1016/j.jmig.2014.08.008. Epub 2014 Aug 14.
Thubert T, Foulot H, Vinchant M, Santulli P, Marzouk P, Borghese B, Chapron C. Surgical treatment: Myomectomy and hysterectomy; Endoscopy: A major advancement. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:104-21. doi: 10.1016/j.bpobgyn.2015.11.021. Epub 2016 Jun 22.
Pakrashi T. New hysteroscopic techniques for submucosal uterine fibroids. Curr Opin Obstet Gynecol. 2014 Aug;26(4):308-13. doi: 10.1097/GCO.0000000000000076.
Vidal-Mazo C, Forero-Diaz C, Lopez-Gonzalez E, Yera-Gilabert M, Machancoses FH. Clinical recurrence of submucosal myoma after a mechanical hysteroscopic myomectomy: Review after 5 years follow up. Eur J Obstet Gynecol Reprod Biol. 2019 Dec;243:41-45. doi: 10.1016/j.ejogrb.2019.10.014. Epub 2019 Oct 21.
van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008 Jul-Aug;15(4):466-71. doi: 10.1016/j.jmig.2008.02.002. Epub 2008 Apr 18.
AlHilli MM, Nixon KE, Hopkins MR, Weaver AL, Laughlin-Tommaso SK, Famuyide AO. Long-term outcomes after intrauterine morcellation vs hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol. 2013 Mar-Apr;20(2):215-21. doi: 10.1016/j.jmig.2012.10.013. Epub 2013 Jan 5.
Li C, Dai Z, Gong Y, Xie B, Wang B. A systematic review and meta-analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions. Int J Gynaecol Obstet. 2017 Jan;136(1):6-12. doi: 10.1002/ijgo.12012. Epub 2016 Nov 7.
Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
Ansari SH, Bigatti G, Aghssa MM. Operative hysteroscopy with the Bigatti shaver (IBS (R)) for the removal of placental remnants. Facts Views Vis Obgyn. 2018 Sep;10(3):153-159.
Bigatti G, Ansari SH, Di W. The 19 Fr. Intrauterine Bigatti Shaver (IBS(R)): a clinical and technical update. Facts Views Vis Obgyn. 2018 Sep;10(3):161-164.
Other Identifiers
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S64797
Identifier Type: -
Identifier Source: org_study_id
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