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Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits

Phase 3
25 Years
50 Years
Not Enrolling
Atypical Endometrial Polyps, Atypical Endometrial Hyperplasia

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Trial Information

Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits

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).

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Five years

Safety Issue:


Principal Investigator

Federica Scrimin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy


Italy: Ministry of Health

Study ID:

RC 23/98



Start Date:

January 1999

Completion Date:

March 2007

Related Keywords:

  • Atypical Endometrial Polyps
  • Atypical Endometrial Hyperplasia
  • Atypical endometrial polyps
  • Atypical Endometrial Hyperplasia
  • Hysteroscopic resection
  • Conservative treatment
  • Fertile women
  • Endometrial Hyperplasia
  • Hyperplasia
  • Polyps
  • Adenoma
  • Uterine Neoplasms