Hysteroscopic Surgery in Treatment of Intrauterine Abnormalities

NCT ID: NCT03265301

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-08-01

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.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Office hysteroscopy

Group Type: OTHER

Hysteroscopy

Intervention Type: PROCEDURE

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 hysteroscopy

Intervention Type: PROCEDURE

will be done in out patient clinic without anesthesia

Conventional hysteroscopy

Group Type: OTHER

Hysteroscopy

Intervention Type: PROCEDURE

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)

Conventional hysteroscopy

Intervention Type: PROCEDURE

will be done in operative room under general anesthesia

Interventions

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)

Intervention Type: PROCEDURE

Office hysteroscopy

will be done in out patient clinic without anesthesia

Intervention Type: PROCEDURE

Conventional hysteroscopy

will be done in operative room under general anesthesia

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

HSIU

Identifier Type: -

Identifier Source: org_study_id