Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490087
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2007-06-20
Brief Title:
Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Operational Hysteroscopy Versus Traditional Surgery Costs and Health Benefits
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 curettageDC 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 20061951328-30
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 05 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
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 20061951328-30
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None