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

Hadassah Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Tissue Adhesions

Treatments: Drug: Hyaluronan

Study type: Interventional

Funder types: Other

Identifiers

NCT01464528

HYALOBARRIER- HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Hyaluronan

Active Comparator group

Description:

Use of hyaluronic acid gel

Treatment:

Drug: Hyaluronan

control

No Intervention group