Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
Primary Purpose
Atypical Endometrial Polyps, Atypical Endometrial Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Levonorgestrel intrauterine device (IUD)
Sponsored by
About this trial
This is an interventional treatment trial for Atypical Endometrial Polyps focused on measuring Atypical endometrial polyps, Atypical Endometrial Hyperplasia, Hysteroscopic resection, Conservative treatment, Fertile women
Eligibility 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
Sites / Locations
- Institute of Child Health, IRCCS Burlo Garofolo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hysteroscopic resection plus IUD
Hysteroscopic resection without IUD
Arm Description
Outcomes
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
Secondary Outcome Measures
Recurrence rate of polyp in the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00490087
Brief Title
Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
Official Title
Operational Hysteroscopy Versus Traditional Surgery: Costs and Health Benefits
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS Burlo Garofolo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Endometrial Polyps, Atypical Endometrial Hyperplasia
Keywords
Atypical endometrial polyps, Atypical Endometrial Hyperplasia, Hysteroscopic resection, Conservative treatment, Fertile women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hysteroscopic resection plus IUD
Arm Type
Experimental
Arm Title
Hysteroscopic resection without IUD
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Levonorgestrel intrauterine device (IUD)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Recurrence rate of polyp in the two groups
Time Frame
Five years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federica Scrimin, MD
Organizational Affiliation
Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Child Health, IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18928975
Citation
Scrimin F, Wiesenfeld U, Candiotto A, Inglese S, Ronfani L, Guaschino S. Resectoscopic treatment of atypical endometrial polyps in fertile women. Am J Obstet Gynecol. 2008 Oct;199(4):365.e1-3. doi: 10.1016/j.ajog.2008.03.041.
Results Reference
result
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Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
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