Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Study Overview
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Brief Summary
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Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

Detailed Description
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Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.

Official Title
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Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Conditions
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Tissue Adhesions

Intervention / Treatment
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* Drug: Hyaluronan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 year old and over need of hysteroscopic surgery Exclusion Criteria: preoperative fever or infection malignancy previous PID contraindications for anesthesia pregnancy under 18 year old not able to read and/or understand informed consent taking any medicine other than oral contraceptives

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronan<br>Use of hyaluronic acid gel | Drug: Hyaluronan<br>* single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery<br>* Other names: hyaluronic acid, alcohol and carboxil;|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction following gel application |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopy, postoperative complications, adhesions, hyaluronic gel, prevention