UMIN-CTR Clinical Trial

Public title

Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia

Acronym

Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia

Scientific Title

Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia

Scientific Title:Acronym

Clinical evaluation of small diameter hysteroscopic morcellator system for endometrial polypectomy: A prospective study of office-based surgery without anesthesia

Region

Japan

Condition

Endometrial polyp
Retained products of conception (RPOC)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of hysteroscopic endometrial polypectomy using hysteroscopic morcellator system without anesthesia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Success rate of surgery

Key secondary outcomes

1. Operating time
2. Running time of morcellator
3. Fluid deficit
4. Insertion time during surgery
5. Adverse event
6. Pain, expectation, and satisfaction evaluated by patient
7. Recurrence of symptoms
8. Pregnancy rate, time to get pregnant

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Hysteroscopic surgery using TruClear 5c system without anesthesia

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>

Gender

Female

Key inclusion criteria

1. Patients who have required hysteroscopic polypectomy
2. Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement in a format approved by the institution site

Key exclusion criteria

1. Patients with uterus bipartitus
2. Patients with intrauterine adhesion
3. Patients with endometrial carcinoma or suspected endometrial carcinoma
4. Patients who have experienced vasovagal syncope due to intrauterine procedure
5. Patients with endometrial polyp larger than 3 cm in diameter
6. Patients who are judged ineligible by the principal investigator or sub-investigators

Target sample size

75

Name of lead principal investigator

1st name	Osamu
Middle name
Last name	Nishii

Organization

University Hospital, Mizonokuchi, Teikyo University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

2130002

Address

5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan

TEL

044-844-3333

Email

nishii@med.teikyo-u.ac.jp

Name of contact person

1st name	Akira
Middle name
Last name	Tsuchiya

Organization

University Hospital, Mizonokuchi, Teikyo University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

2130002

Address

5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa, Japan

TEL

044-844-3333

Homepage URL

Email

tsuchiya@med.teikyo-u.ac.jp

Institute

Teikyo University

Institute

Department

Personal name

Organization

Teikyo University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of the Faculty of Medicine of Teikyo University

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

Tel

03-3964-7256 ext. 42203

Email

turb-office@teikyo-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京大学医学部附属溝口病院（神奈川県）

Date of disclosure of the study information

2020

Year

08

Month

06

Day

URL releasing protocol

https://journals.lww.com/gmit/fulltext/2024/13030/anesthesia_free_in_office_hysteroscopic.7.aspx

Publication of results

Published

URL related to results and publications

https://journals.lww.com/gmit/fulltext/2024/13030/anesthesia_free_in_office_hysteroscopic.7.aspx

Number of participants that the trial has enrolled

95

Results

Ninety-five patients underwent hysteroscopic morcellation without anesthesia and received the treatment. The success rate of surgery was 100% (95/95), and the mean operating time was 7.3 min. Adverse events occurred in only 2.1% (2/95), with vasovagal reflex. The mean VAS scores during the procedure ranged from 2.4 to 3.1, and the recurrence rate after 6 months was 2.1% (1/47), with a pregnancy rate of 33% (11/33).

Results date posted

2024

Year

07

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

All women with indications for endometrial polypectomy or removal of RPOC were screened for eligibility, and those who declined to participate were excluded. Eligibility was determined based on a diagnostic office hysteroscopy, and exclusion criteria included patients with uterus bipartitus, intrauterine adhesion, endometrial carcinoma or suspected endometrial carcinoma, the experience of vasovagal reflex due to intrauterine procedure, endometrial polyps larger than 3 cm in diameter, or those who were judged ineligible by the principal investigator or subinvestigators. The number of polyps was not a criterion for exclusion. All enrolled participants were allocated to receive in-office hysteroscopic morcellation without anesthesia.

Participant flow

All surgical procedures were performed in the office setting without the use of general anesthesia or conscious sedation. Hysteroscopic morcellation was performed using the TruClear 5C system, with a 5.7-mm sheath, and a 2.9-mm rotary morcellator. Before the operation, a 50 mg diclofenac suppository was administered 30 min before the operation. We attempted to reach the uterine cavity by vaginoscopy. If it was difficult to reach the uterine cavity, the sheath was removed. Cervical dilation was not performed, and a vaginal speculum was not used unless the scope could not access the uterine cavity by vaginoscopy. If the pain during the procedure was intolerable, 30 mg of pentazocine was administered intravenously. Normal saline was used for irrigation with a pressure of 70 mmHg without a specific pump. After introducing the hysteroscope, we thoroughly examined the uterine cavity, then conducted polypectomy, and finished the procedure after confirming the complete removal of the endometrial polyps. After the operation, patients rested for 30 min and completed a questionnaire document containing 10 cm Visual Analog Scale (VAS) scores of pain (0 for no pain and 10 for the worst imaginable pain). Patients recorded the VAS score of the maximum pain during menstruation and the scores before the surgery, during insertion (vaginoscopy), after insertion, during morcellation, and after the surgery. Transvaginal ultrasound sonography was conducted after 2 and 6 months, and symptoms were assessed to determine recurrence.

Adverse events

All patients achieved complete resection without any adverse events including blood loss, infection, or uterine perforation, except for vasovagal reflex in two patients.

Outcome measures

The primary endpoint was the success rate of surgery, defined as the completion of the operation. The secondary endpoints were (1) operating time, (2) fluid deficit, (3) adverse events, (4) patient-evaluated pain, and (5) recurrence rate by transvaginal ultrasonography. Operating time was divided into vaginoscopy time and insertion time. The vaginoscopy time was defined as the time from the visual introduction by the scope until the time the scope reached the uterine cavity, and the insertion time was defined as the time from the time the scope reached the uterine cavity to the time of the completion of the procedure. Therefore, the operating time was equal to the vaginoscopy time plus the insertion time. Furthermore, to further evaluate the sustainability of in-office surgery without anesthesia, we divided the patients into two groups: nulliparous and parous and compared them.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

07

Month

28

Day

Date of IRB

2020

Year

07

Month

28

Day

Anticipated trial start date

2020

Year

08

Month

06

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

08

Month

06

Day

Last modified on

2024

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047093