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

NCT05811286 | Completed

• 1 other identifier: S64797
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Endometrial Polyp Benign; Retained Products of Conception; Myoma;Uterus

Keywords

Endometrial polyp; Hysteroscopic surgery; Morcellation; Retained products of conception; Myoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Operation time

  During surgery

• Need for cervical dilation during procedure

  During surgery

• Volume of distension fluid used / loss (deficit) during procedure

  During surgery

• Operator satisfaction, assessed by verbal rating scale

  At the end of the procedure

• Complications

  6 weeks after surgery

Study Arms (1)

Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions

EXPERIMENTAL

Single experimental arm of patients with a intracavitary lesion and elligible for hysteroscopic morcellation.

Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions

Interventions

Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions PROCEDURE

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.

Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (13)

• 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.

  PMID: 26457853 BACKGROUND

• 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.

  PMID: 27164165 BACKGROUND

• 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.

  PMID: 26744122 BACKGROUND

• 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.

  PMID: 25128851 BACKGROUND

• 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.

  PMID: 27400649 BACKGROUND

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

  PMID: 24950124 BACKGROUND

• 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.

  PMID: 31671290 BACKGROUND

• 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.

  PMID: 18588849 BACKGROUND

• 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.

  PMID: 23295201 BACKGROUND

• 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.

  PMID: 28099700 BACKGROUND

• 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.

  PMID: 32681995 BACKGROUND

• 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.

  PMID: 31191850 BACKGROUND

• 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.

  PMID: 31191851 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Myoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 13, 2023
• Study Start: May 20, 2021
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)