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

Adhesion; Uterus, Internal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446755
• Other study ID #: B670201733915
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: December 16, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 16, 2020
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Related Conditions & MeSH terms

• Adhesion; Uterus, Internal
• Tissue Adhesions

Intervention

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.

Locations

Country	Name	City	State
Belgium	University hospital Ghent	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of recurrent adhesions after adhesiolysis		5-10 weeks after adhesiolysis
Primary	The number of complications after adhesiolysis		5-10 weeks after adhesiolysis
Secondary	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
Secondary	Complications after placement of the intra uterine balloon		1 to 6 days after adhesiolysis
Secondary	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
Secondary	Patient Satisfaction after removal of the intra uterine balloon	Via questionnaire	6 days after adhesiolysis
Secondary	Malaise after placement of the intra uterine balloon	Via questionnaire	6 days after adhesiolysis
Secondary	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
Secondary	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
Secondary	The ease of removing the intra uterine balloon	Via questionnaire	6 days after adhesiolysis