Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169478
Recruitment Status : Unknown
Verified June 2017 by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : May 30, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Xiaoyu Shi, Fu Xing Hospital, Capital Medical University

Brief Summary:

Transcervical resection of submucous myomas (TCRM) is nowadays considered necessary if it is associated with infertility or miscarriage or menorrhagia. Nevertheless, one possible risk of hysteroscopic myomectomy is the formation of intrauterine adhesion (IUA) at the site of resection. The development of IUA arising from trauma to the basalis layer of the endometrium during hysteroscopy can result in infertility, recurrent miscarriages, amenorrhea, dysmenorrhea, or abnormal placentation.

Several measures have been proposed in an effort to decrease the formation of post-surgical intrauterine adhesions. Additionally, physical barriers such as balloon catheters or intrauterine devices have been used in the postoperative period. Despite years of studies evaluating prevention strategies for intrauterine adhesion formation after operative hysteroscopy, it is still unclear which strategy is most effective because there has never been any formal properly powered randomized, control trial to examine the efficacy of the various methods used to prevent adhesion reformation.

In this prospective, randomized, controlled study, the investigators wish to examine the efficacy of intrauterine balloon dilatation therapy in the early postoperative period in preventing adhesion formation after transcervical resection of submucous myomas.


Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Procedure: multiple myoma IUB dilatation group Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy of Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopicremovalof Multiple Fibroids
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: multiple myoma control group
The control group will not have any balloon therapy. A second-look hysteroscopy will be carried out 6 weeks after the surgery.
Experimental: multiple myoma IUB dilatation group
The multiple myoma study group will have Foley-catheter intrauterine balloon dilatation therapy 2 weeks and 4 weeks after hysteroscopic myomectomy. A second-look hysteroscopy will be carried out 6 weeks after the surgery.
Procedure: multiple myoma IUB dilatation group
A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and stretching and blunt dissection of any intrauterine adhesions, if present.




Primary Outcome Measures :
  1. The amount of intrauterine adhesions at second look hysteroscopy [ Time Frame: at 6 weeks post-op ]
    The amount of intrauterine adhesions according to AFS score at second look hysteroscopy


Secondary Outcome Measures :
  1. complications of hysteroscopic myomectomy [ Time Frame: at 6 weeks post-op ]
    complications of hysteroscopic myomectomy including infection rate

  2. menstrual pattern [ Time Frame: at 3 months post-op ]
    The menstrual pattern before and after surgery and the need for re-operation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study focus on intrauterine adhesion only in female patients.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • [1] women aged 18-45 years with regular 25-35 days cycles ;
  • [2] no evidence of intrauterine adhesions at the time of surgery;
  • [3] written consent obtained;
  • [4] agreement to have second-look hysteroscopy;
  • [5] had more than one fibroids removed at the time of hysteroscopic surgery

Exclusion Criteria:

  • [1] women who are already postmenopausal
  • [2] women who have evidence of intrauterine adhesions at the time of surgeryare

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): NCT03169478


Contacts
Layout table for location contacts
Contact: Lei Guo +86 15810635320 guolei.yale@163.com
Contact: Tinchiu Li +86 010 88062944 tinchiu.li@gmail.com

Locations
Layout table for location information
China, Beijing
Fu Xing Hospital Recruiting
Beijing, Beijing, China, 100038
Contact: Lei Guo    +86 010-88062291    guolei.yale@163.com   
Contact: Tinchiu Li, Ph.D.       tinchiuli@gmail.com   
Sponsors and Collaborators
Fu Xing Hospital, Capital Medical University
Beijing Tiantan Hospital
Investigators
Layout table for investigator information
Study Chair: Tinchiu Li Fu Xing Hospital, Capital Medical University
Publications of Results:
Saravelos SH and Li TC. Intrauterine balloon therapy: a novel ultrasound guided treatment for intrauterine adhesions. Gynecological Surgery [Epub ahead of print]

Layout table for additonal information
Responsible Party: Xiaoyu Shi, Principal Investigator, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03169478    
Other Study ID Numbers: 2017FXHEC-KY005
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University:
hysteroscopic myomectomy
balloon dilatation
adhesions
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Tissue Adhesions
Dilatation, Pathologic
Cicatrix
Fibrosis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical