Clinical trial NCT05811286: The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
Official title: The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Polyp Benign
Retained Products of Conception
Myoma;Uterus
Keywords: Endometrial polyp
Hysteroscopic surgery
Morcellation
Retained products of conception
Myoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2023-04-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Completeness of resection of intracavitary lesions in 50 patients, when using a hysteroscopic Bigatti Shaver.
timeFrame: During surgery
Secondary outcomes:
measure: Operation time
timeFrame: During surgery
measure: Need for cervical dilation during procedure
timeFrame: During surgery
measure: Volume of distension fluid used / loss (deficit) during procedure
timeFrame: During surgery
measure: Operator satisfaction, assessed by verbal rating scale
timeFrame: At the end of the procedure
measure: Complications
timeFrame: 6 weeks after surgery
measure: Pain on the first postoperative day, assessed by verbal rating scale
timeFrame: Day 1 post-operatively
measure: Histology of the intracavitary lesion
timeFrame: 6 weeks post-operatively
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
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