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

Immediate and Delayed Intrauterine Balloon 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171454
Recruitment Status : Unknown
Verified June 2017 by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : May 31, 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:
In this prospective, randomized, controlled study, the investigators wish to compare the efficacy of immediate and delayed intrauterine balloon (IUB) therapy in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Procedure: Delayed Intrauterine Balloon therapy Procedure: immediate Intrauterine Balloon therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial Comparing Immediate and Delayed Intrauterine Balloon Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Delayed Intrauterine Balloon therapy
In the delayed balloon group,a Foley catheter will be inserted into the uterine cavity 2 weeks after the surgery, the balloon will be inflated with normal saline (from 3ml to 5ml) then deflated, and the procedure repeated three time over 3 minutes or so, then the cavity will be flushed with 10 mls of normal saline solution after via the irrigating channel of the Foley catheter before removal. The whole procedure will be repeated a further 2 weeks later.
Procedure: Delayed Intrauterine Balloon therapy
D-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.

Experimental: immediate Intrauterine Balloon therapy
At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.
Procedure: immediate Intrauterine Balloon therapy
At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.




Primary Outcome Measures :
  1. AFS score [ Time Frame: at 6 weeks post-op ]
    The degree of intrauterine adhesions described by AFS score reduction at second look hysteroscopy


Secondary Outcome Measures :
  1. The menstrual pattern [ Time Frame: at 6 weeks post-op ]
    Menstrual blood loss figure before and after surgery

  2. infection rate [ Time Frame: at 6 weeks post-op ]
    Secretion bacteria culture



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

Inclusion Criteria:

  • women aged 18-40 years;
  • moderate to severe intrauterine adhesion (AFS score≥5);
  • first episode of hysteroscopicadhesiolysis in our hospital;
  • written consent obtained;
  • agreement to have second-look hysteroscopy.

Exclusion Criteria:

  • minimal adhesion (AFS score <5)
  • previous hysteroscopic adhesiolysis in our hospital.

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): NCT03171454


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       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]

Other Publications:
Layout table for additonal information
Responsible Party: Xiaoyu Shi, Principal Investigator, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03171454    
Other Study ID Numbers: 2017FXHEC-KY006
First Posted: May 31, 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 operation
intrauterine balloon
adhesions
Additional relevant MeSH terms:
Layout table for MeSH terms
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes