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HysteroscopyNCT03265301

Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

A study testing Hysteroscopy, Office hysteroscopy and Conventional hysteroscopy in people with Hysteroscopy, run by Assiut University at 1 site in Egypt.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

With the ongoing developments in the field of hysteroscopy during the past 15 years, hysteroscopic surgery is becoming safer and less invasive for the patient. Improved technology has enabled surgeons to perform many operative procedures in an ambulatory setting without significant patient discomfort and with… Read more about this study

Who is it for?
Ages 20 to 45 years, women only
Conditions the study is for
Hysteroscopy
What is being tested?
Hysteroscopy, Office hysteroscopy and Conventional hysteroscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteEgypt
Study dates
1 Aug 2017to 1 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • infertile women
  • women with recurrent pregnancy loss
  • suspected intrauterine abnormalities

Who cannot join

  • Normal endometrial cavity
  • Endometrial pathologies like polypi or submucous myomata.
  • Extensive intrauterine synechiae

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Women Health Hospital - Assiut university

    Asyut, 71111

Other trials in Egypt

About this study

Official title: Corrective Office Hysteroscopic Surgery Versus Conventional Hysteroscopy in Treatment of Intrauterine Abnormalities

With the ongoing developments in the field of hysteroscopy during the past 15 years, hysteroscopic surgery is becoming safer and less invasive for the patient. Improved technology has enabled surgeons to perform many operative procedures in an ambulatory setting without significant patient discomfort and with potentially significant cost savings.

Office operative hysteroscopy (see and treat hysteroscopy) reduces the distinction between a diagnostic and an operative procedure, shifting the focus in health care away from inpatient diagnosis and treatment. The development of smaller-diameter hysteroscopes with continuous-flow system features and working channels, through which operative instruments can be introduced, has made it possible to treat some uterine and cervical diseases without the traditional need for cervical dilation or general anesthesia.

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Use of specially designed hysteroscopic 5F mechanical instruments (e.g., scissors, biopsy cup, graspers, and corkscrews) has long been the only way to perform operative procedures in an ambulatory setting. However, although grasping forceps and scissors are excellent for treating adhesions, cervical polyps, and endometrial polyps smaller than or the same size as the larger endometrial polyps, or thick lesions (e.g., submucous fibroids) were difficult to treat successfully using such miniature, fragile instruments and without cervical dilation.

An important technologic advance occurred in 1997 with the introduction of a versatile bipolar electrosurgery system dedicated to hysteroscopy, the Gynecare VersaPoint (Ethicon, Inc., Somerville, NJ, USA), which represents a key point in the history of office operative hysteroscopy. With the use of 5F bipolar electrodes, the number of pathologic conditions treated using office operative hysteroscopy has increased tremendously, reducing the use of the resectoscope and the operating room to a smaller number of cases.

More recently, a new generation of electrical generators, allowing the use of bipolar energy on miniaturized electrodes, has been presented (Autocon 400 II; Karl Storz Endoscopy, Tuttlingen, Germany). The main advantage of these instruments is that they are reusable, thereby reducing the costs of office operative as those described for the Versapoint system.

The feasibility of ambulatory uterine surgery is not just dependent on recent technological advances in instrumentation such as miniaturization of equipment, but also the favorable anatomical characteristics of the uterus itself. The sensitive innervations of the uterus originate in the myometrium and extend to the outer serosal surface, whereas the endometrium and any fibrotic tissue within the cavity are less sensitive. Thus, procedures can be carried out without the use of analgesia or anesthesia.

However, a careful operative technique is of paramount importance, in particular, avoiding inadvertent deep penetration of the superficial myometrium when resecting lesions such as polyps, maintaining the lowest possible distension pressures, and expediting procedures through efficient surgical techniques.

Conditions
Hysteroscopy
Being tested
Hysteroscopy, Office hysteroscopy, Conventional hysteroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HysteroscopyProcedure or surgery

    Includes Video set up, mini-hysteroscope system, continuous inflow and outflow, rod lens or fiber optic lens Zero to 30 degree angle and mechanical instruments (Scissors,Graspers , Cup biopsy forceps and bipolar instruments)

  • Office hysteroscopyProcedure or surgery

    will be done in out patient clinic without anesthesia

  • Conventional hysteroscopyProcedure or surgery

    will be done in operative room under general anesthesia

Study groups in NCT03265301
Study groupRoleWhat they receive
Office hysteroscopyOtherNot described
Receives: Procedure: Hysteroscopy; Procedure: Office hysteroscopy
Conventional hysteroscopyOtherNot described
Receives: Procedure: Hysteroscopy; Procedure: Conventional hysteroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 Aug 2017
  3. Primary completion1 Jan 2019
  4. Study completion1 Aug 2019

Why it stopped: The randomization could not be done

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265301
Sponsor's protocol ID
HSIU
Status last verified
Nov 2022
First submitted
27 Aug 2017
Last updated
23 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Hysteroscopy, Office hysteroscopy and Conventional hysteroscopy in people with Hysteroscopy, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.

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