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

Early Phase 1

• Conditions: Tissue Adhesions
• Interventions: Drug: Hyaluronan

• Registration Number: NCT01464528
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-08-15
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-02
• Last Update Submitted: 2011-11-02
• Study First Posted: 2011-11-03
• Last Update Posted: 2011-11-03
• Primary Completion: 2012-03
• Study Completion: 2012-05

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronan	Hyaluronan	Use of hyaluronic acid gel

Primary Outcome Measures

Name	Time	Method
Patient satisfaction following gel application	2 months