Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Completed

CT.gov ID

NCT00490087

Collaborator

(none)

Enrollment

Location

Arms

97.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Atypical Endometrial Polyps Atypical Endometrial Hyperplasia	Device: Levonorgestrel intrauterine device (IUD)	Phase 3

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits

Study Start Date :

Jan 1, 1999

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hysteroscopic resection plus IUD	Device: Levonorgestrel intrauterine device (IUD)
No Intervention: Hysteroscopic resection without IUD

Arm

Intervention/Treatment

Experimental: Hysteroscopic resection plus IUD

Device: Levonorgestrel intrauterine device (IUD)

No Intervention: Hysteroscopic resection without IUD

Outcome Measures

Primary Outcome Measures

Efficacy and prognosis of hysteroscopic resection of atypical polyps in terms of appearance of endometrial cancer or recurrence of atypical endometrial lesions [Five years]

Secondary Outcome Measures

Recurrence rate of polyp in the two groups [Five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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.