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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrauterine balloon (Cook medical) | Experimental | Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra uterine Cook balloon | Device | Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. |
| 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 |
| 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 |
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Inclusion Criteria:
Only female patients will be included
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Ghent | Ghent | East-Flanders | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36541390 | Derived | van Wessel S, Wauters L, Weyers S, Hamerlynck T. The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study. J Obstet Gynaecol. 2022 Nov;42(8):3720-3724. doi: 10.1080/01443615.2022.2158320. Epub 2022 Dec 21. |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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 |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |