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

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT05811286

Collaborator

Ziekenhuis Oost-Limburg (Other)

Enrollment

Locations

Arm

24.4

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Polyp Benign Retained Products of Conception Myoma;Uterus	Procedure: Hysteroscopic morcellation 19 Fr. intrauterine BIGATTI Shaver for uterine intracavitary lesions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

Operation time [During surgery]
total operation time and time necessary for the morcellation
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?
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.
Complications [6 weeks after surgery]
Adverse events during procedure/hospitalization and within the first 6 weeks after procedure
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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