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Sponsored by: |
IRCCS Burlo Garofolo |
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Information provided by: | IRCCS Burlo Garofolo |
ClinicalTrials.gov Identifier: | NCT00490087 |
The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.
Condition | Intervention | Phase |
---|---|---|
Atypical Endometrial Polyps Atypical Endometrial Hyperplasia |
Procedure: Hysteroscopic resection Device: Levonorgestrel intrauterine device (IUD) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits |
Enrollment: | 21 |
Study Start Date: | January 1999 |
Study Completion Date: | March 2007 |
The introduction of hysteroscopy in clinical practice changed significantly our knowledge of uterine cavity, but did not stimulate the start of big studies with aim to evaluate the feasibility of conservative treatments for better defined diseases as endometrial polyp. The use of curettage(D&C) has led the gynecologists to consider diffuse atypical endometrial hyperplasia and atypical polyp as the same disease. The treatment of these precancerous lesions recommended by scientific societies is aggressive (hysterectomy). Surprisingly, regarding hysterectomy we did not observe management modifications after the introduction of endoscopic techniques, as happened in other surgical disciplines.
To evaluate costs and health benefits of operational hysteroscopy we started in our Institute a study protocol in 1998. In a first trial we studied a conservative treatment of postmenopausal woman with high anesthesiologic risk who had endometrial polyps with atypia and no involvement of the base (Scrimin F. Am J Obstet Gynecol 2006;195:1328-30).
The good initial results and the request of conservative treatments by some women, desiring pregnancies, encouraged us to start this preliminary trial to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in a little sample of fertile women. Other studies suggest progestin treatment of well differentiated carcinoma in young women who desired to preserve their fertility. There is no evidence of a correlation between the tendency to develop endometrial polyps and the risk of endometrial carcinoma. The risk of malignant degeneration of endometrial polyps is not well known, but seems to range between 0.5% and 6%. On this background, we decided to study in the same population of fertile women and with a quasi-randomised design the possible additional effect of levonorgestrel–releasing intrauterine device (LNG-IUD).
Comparison: women assigned to odd numbers underwent polyp resection and endometrial surveillance with insertion of levonorgestrel intrauterine system (IUD group), women assigned to even numbers underwent polyp resection and endometrial surveillance without insertion of levonorgestrel intrauterine system (no IUD or control group).
Ages Eligible for Study: | 25 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy, Friuli Venezia Giulia | |
Institute of Child Health, IRCCS Burlo Garofolo | |
Trieste, Friuli Venezia Giulia, Italy, 34137 |
Principal Investigator: | Federica Scrimin, MD | Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy |
Study ID Numbers: | RC 23/98 |
Study First Received: | June 20, 2007 |
Last Updated: | June 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00490087 History of Changes |
Health Authority: | Italy: Ministry of Health |
Atypical endometrial polyps Atypical Endometrial Hyperplasia Hysteroscopic resection Conservative treatment Fertile women |
Pathological Conditions, Anatomical Genital Diseases, Female Hyperplasia Contraceptive Agents Levonorgestrel |
Contraceptives, Oral Contraceptive Agents, Female Uterine Diseases Polyps Endometrial Hyperplasia |
Pathological Conditions, Anatomical Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Uterine Diseases Polyps Reproductive Control Agents |
Pharmacologic Actions Genital Diseases, Female Hyperplasia Pathologic Processes Therapeutic Uses Levonorgestrel Contraceptives, Oral, Synthetic Endometrial Hyperplasia |