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

July 13, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Leuven, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
Time Frame: 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.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: During surgery
total operation time and time necessary for the morcellation
During surgery
Need for cervical dilation during procedure
Time Frame: During surgery
Was it necessary to perform any dilatation with
During surgery
Volume of distension fluid used / loss (deficit) during procedure
Time Frame: During surgery
Deficit in fluid used during surgery?
During surgery
Operator satisfaction, assessed by verbal rating scale
Time Frame: 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.
At the end of the procedure
Complications
Time Frame: 6 weeks after surgery
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
Time Frame: Day 1 post-operatively
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
Time Frame: 6 weeks post-operatively

Incidence of histological outcomes such as endometrial polyps, intracavitary myomas or remnant products of conception.

This is a categorical variable.
6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Ziekenhuis Oost-Limburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share general descriptive characteristics of our cohort. This includes patient and operative characteristics, final histology and patient and doctor reported outcomes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe