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Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

Primary Purpose

Hysteroscopy

Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hysteroscopy
Office hysteroscopy
Conventional hysteroscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hysteroscopy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Office hysteroscopy

Conventional hysteroscopy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2017
Last Updated
November 19, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03265301
Brief Title
Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities
Official Title
Corrective Office Hysteroscopic Surgery Versus Conventional Hysteroscopy in Treatment of Intrauterine Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The randomization could not be done
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Office hysteroscopy
Arm Type
Other
Arm Title
Conventional hysteroscopy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Office hysteroscopy
Intervention Description
will be done in out patient clinic without anesthesia
Intervention Type
Procedure
Intervention Name(s)
Conventional hysteroscopy
Intervention Description
will be done in operative room under general anesthesia
Primary Outcome Measure Information:
Title
Number of uterine abnormalities which will be treated successfully by office and conventional hysteroscopy
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women women with recurrent pregnancy loss suspected intrauterine abnormalities Exclusion Criteria: Normal endometrial cavity Endometrial pathologies like polypi or submucous myomata. Extensive intrauterine synechiae
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

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