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

Not Applicable

Completed

• Conditions: Adhesion; Uterus, Internal
• Interventions: Device: intra uterine Cook balloon

• Registration Number: NCT03446755
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-17
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-27
• Primary Completion: 2020-12-16
• Study Completion: 2020-12-16
• Status Verified: 2021-06
• Last Update Submitted: 2021-07-01
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrauterine balloon (Cook medical)	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.

Primary Outcome Measures

Name	Time	Method
The number of complications after adhesiolysis	5-10 weeks after adhesiolysis
The number of recurrent adhesions after adhesiolysis	5-10 weeks after adhesiolysis

Secondary Outcome Measures

Name	Time	Method
Pain at the time of the removal of the intra uterine balloon	6 days after adhesiolysis	via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)	6 days after adhesiolysis	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).
Pain after placement of the intra uterine balloon	1 to 6 days after adhesiolysis	via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Patient Satisfaction after removal of the intra uterine balloon	6 days after adhesiolysis	Via questionnaire
Complications after placement of the intra uterine balloon	1 to 6 days after adhesiolysis
Malaise after placement of the intra uterine balloon	6 days after adhesiolysis	Via questionnaire
The ease of inserting the intra uterine balloon	once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study	Via questionnaire
The ease of removing the intra uterine balloon	6 days after adhesiolysis	Via questionnaire

Trial Locations

Locations (1)

University hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium