The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study

Myoma;Uterus Clinical Trial

Official title:

The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811286
• Other study ID #: S64797
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: June 28, 2023

Study information

• Verified date: February 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients:

• 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:

• • Active vaginal bleeding

• (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

Related Conditions & MeSH terms

• Leiomyoma
• Myoma;Uterus
• Retained Products of Conception

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	University Hospitals Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pakrashi T. New hysteroscopic techniques for submucosal uterine fibroids. Curr Opin Obstet Gynecol. 2014 Aug;26(4):308-13. doi: 10.1097/GCO.0000000000000076. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.	If all tissue could be removed by the 19 Fr. intrauterine BIGATTI Shaver by direct visualisation at the end of the hysteroscopic procedure and at post-operative ultrasound evaluation.	During surgery
Secondary	Operation time	total operation time and time necessary for the morcellation	During surgery
Secondary	Need for cervical dilation during procedure	Was it necessary to perform any dilatation with	During surgery
Secondary	Volume of distension fluid used / loss (deficit) during procedure	Deficit in fluid used during surgery?	During surgery
Secondary	Operator satisfaction, assessed by verbal rating scale	Operator satisfaction in terms of technique, ergonomics and general proceedings.; The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.	At the end of the procedure
Secondary	Complications	Adverse events during procedure/hospitalization and within the first 6 weeks after procedure	6 weeks after surgery
Secondary	Pain on the first postoperative day, assessed by verbal rating scale	Pain on the first day post-operatively. The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.	Day 1 post-operatively
Secondary	Histology of the intracavitary lesion	Incidence of histological outcomes such as endometrial polyps, intracavitary myomas or remnant products of conception.; This is a categorical variable.	6 weeks post-operatively