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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | total operation time and time necessary for the morcellation | During surgery | 
| Need for cervical dilation during procedure | Was it necessary to perform any dilatation with | During surgery | 
| Volume of distension fluid used / loss (deficit) during procedure | Deficit in fluid used during surgery? | During surgery | 
| 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 | 
| Complications | Adverse events during procedure/hospitalization and within the first 6 weeks after procedure | 6 weeks after surgery | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial polyp, Hysteroscopic surgery, Morcellation, Retained products of conception, Myoma