Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

IRCCS Burlo Garofolo

Status and phase

Completed

Phase 3

Conditions

Atypical Endometrial Polyps

Atypical Endometrial Hyperplasia

Treatments

Device: Levonorgestrel intrauterine device (IUD)

Study type

Interventional

Funder types

Other

Identifiers

NCT00490087

RC 23/98

Details and patient eligibility

About

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.

Full description

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).

Enrollment

21 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

women in fertile age desiring to preserve their uterus
atypical polyps, without atypia in the base. The hysteroscopic and histologic criteria for inclusion in the study were: proliferative, secretive, dysfunctional endometrium or simple hyperplasia in 4 random biopsies.

Exclusion criteria