An interventional study of intra uterine Cook balloon in Adhesion; Uterus, Internal, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Device feasibility
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.
Inclusion Criteria:
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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Ghent