Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
Condition: Atypical Endometrial Polyps; Atypical Endometrial Hyperplasia
MeSH terms: Uterine Neoplasms; Endometrial Hyperplasia; Polyps; Hyperplasia
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Levonorgestrel intrauterine device (IUD)
Intervention type(s): Device
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atypical endometrial polyps; Atypical Endometrial Hyperplasia; Hysteroscopic resection; Conservative treatment; Fertile women