NCT03446755

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adhesion; Uterus, Internal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-17
• Primary completion: 2020-12-16
• Completion: 2020-12-16
• First posted: 2018-02-27
• Last updated: 2021-07-02

Locations

1 site across 1 country: Belgium