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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
University hospital Ghent
Ghent, East-Flanders, Belgium
The number of recurrent adhesions after adhesiolysis
Time frame: 5-10 weeks after adhesiolysis
The number of complications after adhesiolysis
Time frame: 5-10 weeks after adhesiolysis
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).
Time frame: 1 to 6 days after adhesiolysis
Complications after placement of the intra uterine balloon
Time frame: 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).
Time frame: 6 days after adhesiolysis
Patient Satisfaction after removal of the intra uterine balloon
Via questionnaire
Time frame: 6 days after adhesiolysis
Malaise after placement of the intra uterine balloon
Via questionnaire
Time frame: 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).
Time frame: 6 days after adhesiolysis
The ease of inserting the intra uterine balloon
Via questionnaire
Time frame: 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
Time frame: 6 days after adhesiolysis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.