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Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617108
Recruitment Status : Not yet recruiting
First Posted : November 30, 2015
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Xiao Yu, Fu Xing Hospital, Capital Medical University

Brief Summary:
Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.

Condition or disease Intervention/treatment Phase
Uterine Septum Device: Foley balloon Not Applicable

Detailed Description:
The uterine septum (US) is the most common congenital uterine malformation, accounting for about 75% of Mullerian anomalies. Transcervical resection of septum (TCRS) has been shown in several cohort studies to improve outcome, although evidence from prospectively conducted randomized trial is lacking. TCRS is generally considered to be safe but there is a concern that it may be complicated by post-operative formation of intrauterine adhesions. Some investigators therefore recommend the use of postoperative adjuvant therapies with a view to preventing adhesion formation, as in the case of hysteroscopic surgery for Asherman syndrome. The adjuvant measures proposed include postoperative estrogen therapy, the placement of an intrauterine device (IUD) or Foley catheter in the uterine cavity. Unlike the case of Asherman syndrome in which these various adjuvant therapies are often used and appear to be of benefit, it is uncertain if any of these adjuvant measures are of benefit or necessary in the case TCRS. In this study, the investigators will compare the postoperative adhesion formation rates who will receive Foley catheter therapies 、postoperative estrogen therapy and those who will not receive any therapies to determine the usefulness of Foley catheter therapies in reducing postoperative adhesion formation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial Comparing the Efficacy of Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: Foley balloon
Foley balloon following TCRS: a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.
Device: Foley balloon
a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.

No Intervention: control groups
control groups: women will not receive any therapy of the treatment (comparison group).
Experimental: postoperative estrogen therapy groups
Subjects received postoperative hormone therapy as per the protocol in use in our center for Asherman Syndrome. Immediately after the operation, the subjects were started on a 3- month course of cyclical hormonal therapy, consisting of orally administrated oestradiol valerate 2-4mg/day for 21 days, orally administrated medroxyprogesterone acetate 8mg /day from day 12 to 21 of the oestradiol valerate therapy. The second treatment cycle started one week after the completion of the first cycle, and the third treatment cycle started one week after the second cycle.
Device: Foley balloon
a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.




Primary Outcome Measures :
  1. A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy [ Time Frame: 1 year ]
    the incidence and severity of adhesions (as measured according to the American Fertility Society scoring system) between the groups



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
  • Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
  • Written informed consent obtained.

Exclusion Criteria:

  • ongoing pregnancy;
  • Peroperative fever or infections;
  • Malignancy;
  • Precious pelvic inflammatory disease;
  • Uterine fibroid (>3cm size);
  • endometriosis;
  • Contraindications for anesthesia;
  • Not able to read and/or understand informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617108


Contacts
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Contact: Yu Xiao, Ph.D. +86-18601262217 729995176@qq.com

Sponsors and Collaborators
Fu Xing Hospital, Capital Medical University
Investigators
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Study Director: Tinchiu Li, Ph.D. Chinese University of Hong Kong

Publications:
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Responsible Party: Xiao Yu, Dr., Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT02617108    
Other Study ID Numbers: FuXingH2
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Yu, Fu Xing Hospital, Capital Medical University:
uterine septum
intrauterine adhesions
Foley balloon
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs