Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
|ClinicalTrials.gov Identifier: NCT00490087|
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : September 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Atypical Endometrial Polyps Atypical Endometrial Hyperplasia||Device: Levonorgestrel intrauterine device (IUD)||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
|Experimental: Hysteroscopic resection plus IUD||Device: Levonorgestrel intrauterine device (IUD)|
|No Intervention: Hysteroscopic resection without IUD|
- Efficacy and prognosis of hysteroscopic resection of atypical polyps in terms of appearance of endometrial cancer or recurrence of atypical endometrial lesions [ Time Frame: Five years ]
- Recurrence rate of polyp in the two groups [ Time Frame: Five years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490087
|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|