Endometrial Polyps: Pathophysiology and Clinical Consequences

NCT00247923 | Completed

• 2 other identifiers: PP I/II/III22200205
• Study Type: interventional
• Target: 1,186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Polyp; Endometrial Cancer

Keywords

Endometrial polyps.; Angiogenesis.; Asymptomatic.; Symptoms.; Malignancy.; Treatment efficiency.; Vaginal bleeding.

Outcome Measures

Primary Outcomes (4)

• Study part 1. Angiogenesis factor levels in endometrial biopsies in patients with endometrial polyps compared to patients with endometrial cancer

• Resistance in the feeding vessel measured by doppler examination combined with intravenous (i.v.) contrast in patients with endometrial polyps and endometrial cancer

• Study part 2. Change in pictorial blood loss assessment chart (PBAC) score in intervention compared to observation group

• Study part 3. Change in PBAC score in women with endometrial polyps compared to control group

Secondary Outcomes (2)

• Associated factors for the development of endometrial polyps

• Change in endometrial polyp size and symptoms after 6 and 12 months of observation

Interventions

Hysteroscopic resection of endometrial polyps. (TCRP) PROCEDURE

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study 1:
• Endometrial polyp (EP) group: Presence of endometrial polyp verified by vaginal ultrasound examination.
• Cancer group: Presence of endometrial cancer verified by histological examination.
• Study 2:
• Pre- or perimenopausal women.
• Presence of endometrial polyp verified by vaginal ultrasound.
• Study 3:
• EP group: Presence of endometrial polyp verified by vaginal ultrasound.
• Control group: Normal endometrium by vaginal ultrasound examination.

You may not qualify if:

• Study 1: Earlier severe allergic reactions.
• Study 2:
• Postmenopausal patient.
• Pregnancy.
• Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.
• Study 3:
• Previous hysterectomy.
• Pregnancy.
• Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Gynaecologial department, Ullevaal University Hospital

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olav Istre, MD., PhD.

  Department og Gynaecology, Ullevaal University Hospital, Oslo, Norway.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: October 1, 2005
• Study Completion: February 1, 2009
• Last Updated: July 6, 2011

Record last verified: 2009-02

Locations

NO (1)