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Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)

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: NCT03446755
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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Brief Summary:

Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.

A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.

We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.


Condition or disease Intervention/treatment Phase
Adhesion; Uterus, Internal Device: intra uterine Cook balloon Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: To evaluate the feasibility of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis in terms of surgeon's and patient's experience.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : December 16, 2020
Actual Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intrauterine balloon (Cook medical)
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
 Device: intra uterine Cook balloon
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.


Outcome Measures
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Primary Outcome Measures :
  1. The number of recurrent adhesions after adhesiolysis [ Time Frame: 5-10 weeks after adhesiolysis ]
  2. The number of complications after adhesiolysis [ Time Frame: 5-10 weeks after adhesiolysis ]

Secondary Outcome Measures :
  1. Pain after placement of the intra uterine balloon [ Time Frame: 1 to 6 days after adhesiolysis ]
    via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).

  2. Complications after placement of the intra uterine balloon [ Time Frame: 1 to 6 days after adhesiolysis ]
  3. Pain at the time of the removal of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).

  4. Patient Satisfaction after removal of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire

  5. Malaise after placement of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire

  6. Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life) [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire and via via Visual Analogue Scale (VAS scale). The patient has to indicate her daily functioning from 0 (the balloon had no influence on my daily function) to 10 (because of the balloon I couldn't do anything of my daily work).

  7. The ease of inserting the intra uterine balloon [ Time Frame: once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study ]
    Via questionnaire

  8. The ease of removing the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female patients will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
Contacts and Locations
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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): NCT03446755


Locations
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Belgium
University hospital Ghent
Ghent, East-Flanders, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
More Information
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03446755    
Other Study ID Numbers: B670201733915
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University Hospital, Ghent:
antiadhesion treatment
Asherman's syndrome
hysteroscopic adhesiolysis
intrauterine adhesions
intrauterine balloon
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes