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Completed

NCT Number: NCT03446755

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

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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Key information

Conditions

Adhesion; Uterus, Internal Cicatrix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Gynatresia Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Treatment and study plan

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.

Primary outcomes

  1. The number of recurrent adhesions after adhesiolysis

    Time frame: 5-10 weeks after adhesiolysis

  2. The number of complications after adhesiolysis

    Time frame: 5-10 weeks after adhesiolysis

Secondary outcomes

  1. Pain after placement of the intra uterine balloon

    Time frame: 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).

  2. Complications after placement of the intra uterine balloon

    Time frame: 1 to 6 days after adhesiolysis

  3. Pain at the time of the removal of the intra uterine balloon

    Time frame: 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).

  4. Patient Satisfaction after removal of the intra uterine balloon

    Time frame: 6 days after adhesiolysis

    Via questionnaire

  5. Malaise after placement of the intra uterine balloon

    Time frame: 6 days after adhesiolysis

    Via questionnaire

  6. Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)

    Time frame: 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).

  7. The ease of inserting the intra uterine balloon

    Time frame: once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study

    Via questionnaire

  8. The ease of removing the intra uterine balloon

    Time frame: 6 days after adhesiolysis

    Via questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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