Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03265301
Collaborator
(none)
70
1
2
19
3.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hysteroscopy
  • Procedure: Office hysteroscopy
  • Procedure: Conventional hysteroscopy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Corrective Office Hysteroscopic Surgery Versus Conventional Hysteroscopy in Treatment of Intrauterine Abnormalities
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Office hysteroscopy

Procedure: Hysteroscopy
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)

Procedure: Office hysteroscopy
will be done in out patient clinic without anesthesia

Other: Conventional hysteroscopy

Procedure: Hysteroscopy
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)

Procedure: Conventional hysteroscopy
will be done in operative room under general anesthesia

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women Health Hospital - Assiut university Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT03265301
Other Study ID Numbers:
  • HSIU
First Posted:
Aug 29, 2017
Last Update Posted:
Aug 29, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2017