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.
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.
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.
Read more
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 group | Role | What they receive |
|---|---|---|
| Office hysteroscopy | Other | Not described Receives: Procedure: Hysteroscopy; Procedure: Office hysteroscopy |
| Conventional hysteroscopy | Other | Not described Receives: Procedure: Hysteroscopy; Procedure: Conventional hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Jan 2019
- Study completion1 Aug 2019
Why it stopped: The randomization could not be done
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrective Office Hysteroscopic Surgery Versus Conventional Hysteroscopy in Treatment of Intrauterine Abnormalities
- ClinicalTrials.gov ID
- NCT03265301
- Acronym / sponsor ID
- HSIU
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The randomization could not be done
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office hysteroscopy | Other | Procedure: Hysteroscopy, Procedure: Office hysteroscopy |
| Conventional hysteroscopy | Other | Procedure: Hysteroscopy, Procedure: Conventional hysteroscopy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertile women
- women with recurrent pregnancy loss
- suspected intrauterine abnormalities
Key exclusion criteria (3 listed)
- Normal endometrial cavity
- Endometrial pathologies like polypi or submucous myomata.
- Extensive intrauterine synechiae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteroscopyIncludes 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) | Procedure or surgery | Conventional hysteroscopy, Office hysteroscopy |
| Office hysteroscopywill be done in out patient clinic without anesthesia | Procedure or surgery | Office hysteroscopy |
| Conventional hysteroscopywill be done in operative room under general anesthesia | Procedure or surgery | Conventional hysteroscopy |
Primary outcome
Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.