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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Adhesion; Uterus, Internal

Treatments: Device: intra uterine Cook balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03446755

B670201733915

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Intrauterine balloon (Cook medical)

Experimental group

Description:

Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.

Treatment:

Device: intra uterine Cook balloon