Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

NCT ID: NCT00490087

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2007-03-31

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.

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).

Conditions

Atypical Endometrial Polyps; Atypical Endometrial Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hysteroscopic resection plus IUD

Group Type: EXPERIMENTAL

Levonorgestrel intrauterine device (IUD)

Intervention Type: DEVICE

Hysteroscopic resection without IUD

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Levonorgestrel intrauterine device (IUD)

Intervention Type: DEVICE

Eligibility Criteria

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

• women with adenomatous or atypical hyperplasia in the random biopsies

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Principal Investigators

Federica Scrimin, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy

Locations

Institute of Child Health, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Countries

Italy

References

Scrimin F, Wiesenfeld U, Candiotto A, Inglese S, Ronfani L, Guaschino S. Resectoscopic treatment of atypical endometrial polyps in fertile women. Am J Obstet Gynecol. 2008 Oct;199(4):365.e1-3. doi: 10.1016/j.ajog.2008.03.041.

Reference Type: RESULT

PMID: 18928975 (View on PubMed)

Other Identifiers

RC 23/98

Identifier Type: -

Identifier Source: org_study_id