Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women

This study has been completed.
Sponsor:
Information provided by:
IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00490087
First received: June 20, 2007
Last updated: September 1, 2011
Last verified: June 2007
  Purpose

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
Device: Levonorgestrel intrauterine device (IUD)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

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 [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence rate of polyp in the two groups [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: January 1999
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hysteroscopic resection plus IUD Device: Levonorgestrel intrauterine device (IUD)
No Intervention: Hysteroscopic resection without IUD

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).

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490087

Locations
Italy
Institute of Child Health, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Principal Investigator: Federica Scrimin, MD Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00490087     History of Changes
Other Study ID Numbers: RC 23/98
Study First Received: June 20, 2007
Last Updated: September 1, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Burlo Garofolo:
Atypical endometrial polyps
Atypical Endometrial Hyperplasia
Hysteroscopic resection
Conservative treatment
Fertile women

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Polyps
Uterine Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Pathological Conditions, Anatomical
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 11, 2014