Endometrial Polyps: Pathophysiology and Clinical Consequences
Condition: Endometrial Polyp; Endometrial Cancer
MeSH terms: Endometrial Neoplasms; Uterine Neoplasms; Polyps
Study type: Interventional

Summary: 
      The aim of these studies is to study the natural history, the symptoms of, as well as the
      effect of hysteroscopic resection of endometrial polyps. Furthermore, another aim is to study
      new diagnostic techniques to differentiate between malignant and benign endometrial polyps.
    

Detailed description: 
      Study Part 1: New diagnostic methods for the prediction of malignancy in endometrial polyps:
      A prospective pilot study.

      Study of angiogenesis by identification of specific angiogenesis factors in tissue biopsies
      from the endometrium and by Doppler ultrasound combined with IV contrast. We hope to find
      specific characteristics with new vessel formation in the endometrial polyp, which can play a
      role in the prognostic evaluation regarding the risk for cancer development. We will compare
      women with endometrial polyps and women with endometrial cancer to see if these methods of
      angiogenesis evaluation may be useful in separating benign polyps from premalignant and
      malignant polyps.

      Study Part 2: The natural history of endometrial polyps. A prospective randomised study of
      patients with endometrial polyps.

      Blood loss during menstruation is documented with the help of a standardized form (PBAC). The
      patients are randomized to hysteroscopic resection of the endometrial polyp or 6 months of
      observation. A new registration of blood loss during menstruation is performed by patients in
      both groups. In the intervention group, a new gynaecological examination 6 months after the
      resection documents the presence of residual polyp or symptoms. The other group is examined
      again after 6 months of observation. Symptoms and findings with the second examination are
      compared with symptoms and findings at the first examination, any changes are documented and
      the final outcome in the to groups are compared.

      Study Part 3: The occurrence and natural history of asymptomatic endometrial polyps in
      perimenopausal women. A prospective controlled study.

      Registration of blood loss during menstruation is documented with the help of a standardized
      form (PBAC) and gynaecological examination including SIS of 1000 randomly selected women in
      the age group 45-50. Where endometrial polyps are identified, we document the size and number
      of polyps and an endometrial biopsy is taken. After including a woman with an endometrial
      polyp in the study, the next woman without endometrial polyp is recruited to the control
      group. After one year, blood loss during menstruation is registered again, and all women with
      endometrial polyps as well as the control group have a new examination including vaginal
      ultrasound, SIS and endometrial biopsy. Symptoms and findings are compared with symptoms and
      findings at the first examination and all changes are documented. If the woman has a
      persistent endometrial polyp when examined at 1 year, she is offered treatment with
      hysteroscopic polyp resection.
    

Intervention name(s): Hysteroscopic resection of endometrial polyps. (TCRP)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial polyps.; Angiogenesis.; Asymptomatic.; Symptoms.; Malignancy.; Treatment efficiency.; Vaginal bleeding.