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

Study Overview
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Brief Summary
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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.

Official Title
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The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.

Conditions
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Adhesion; Uterus, Internal

Intervention / Treatment
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* Device: intra uterine Cook balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrauterine balloon (Cook medical)<br>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<br>* Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of recurrent adhesions after adhesiolysis |  | 5-10 weeks after adhesiolysis | 
| The number of complications after adhesiolysis |  | 5-10 weeks after adhesiolysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after placement of the intra uterine balloon | via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever). | 1 to 6 days after adhesiolysis | 
| Complications after placement of the intra uterine balloon |  | 1 to 6 days after adhesiolysis | 
| Pain at the time of the removal of the intra uterine balloon | via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever). | 6 days after adhesiolysis | 
| Patient Satisfaction after removal of the intra uterine balloon | Via questionnaire | 6 days after adhesiolysis | 
| Malaise after placement of the intra uterine balloon | Via questionnaire | 6 days after adhesiolysis | 
| Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life) | 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). | 6 days after adhesiolysis | 
| The ease of inserting the intra uterine balloon | Via questionnaire | once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study | 
| The ease of removing the intra uterine balloon | Via questionnaire | 6 days after adhesiolysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon