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

Not Applicable

Completed

• Conditions: Endometrial Polyp Benign; Retained Products of Conception; Myoma;Uterus
• Interventions: Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions

• Registration Number: NCT05811286
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-13
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.	During surgery	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.

Secondary Outcome Measures

Name	Time	Method
Complications	6 weeks after surgery	Adverse events during procedure/hospitalization and within the first 6 weeks after procedure
Histology of the intracavitary lesion	6 weeks post-operatively	Incidence of histological outcomes such as endometrial polyps, intracavitary myomas or remnant products of conception.; This is a categorical variable.
Operation time	During surgery	total operation time and time necessary for the morcellation
Operator satisfaction, assessed by verbal rating scale	At the end of the procedure	Operator satisfaction in terms of technique, ergonomics and general proceedings.; The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.
Need for cervical dilation during procedure	During surgery	Was it necessary to perform any dilatation with
Volume of distension fluid used / loss (deficit) during procedure	During surgery	Deficit in fluid used during surgery?
Pain on the first postoperative day, assessed by verbal rating scale	Day 1 post-operatively	Pain on the first day post-operatively. The verbal rating scale includes Very negative; Negative; Intermediate; Positive; Very positive.

Trial Locations

Locations (2)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

University Hospitals Leuven; 🇧🇪 Leuven, Belgium