Adhesion; Uterus, Internal
Conditions
Keywords
antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon
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.
Interventions
DEVICEintra uterine Cook balloon
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain at the time of the removal of the intra uterine balloon | 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). |
| Patient Satisfaction after removal of the intra uterine balloon | 6 days after adhesiolysis | Via questionnaire |
| Malaise after placement of the intra uterine balloon | 6 days after adhesiolysis | Via questionnaire |
| Pain after placement of the intra uterine balloon | 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). |
| The ease of inserting the intra uterine balloon | once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study | Via questionnaire |
| The ease of removing the intra uterine balloon | 6 days after adhesiolysis | Via questionnaire |
| Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life) | 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). |
| Complications after placement of the intra uterine balloon | 1 to 6 days after adhesiolysis | — |
Countries
Belgium
Outcome results
None listed