5.2 Indications
The LEEP procedure is indicated in the diagnosis and treatment of some Cervical Intraepithelial
Neoplasia (CIN) in patients where there is:
•
Cytological or colposcopic suspicion of CIN 2 or worse (including micro-invasion)
•
Persistent CIN 1 (of more than 12 months duration)
•
CIN 1 where the likelihood of follow-up is low or when the patient requests treatment
•
A suspicion (cytological or colposcopic) of a glandular intraepithelial abnormality
•
A disparity between the cytological and colposcopic diagnoses
•
External anogenital lesion
•
Large vaginal intraepithelial neoplastic (VAIN) lesions
•
Cervical conization indications
5.3 Contraindications
The following are typical contraindications for performing the LEEP procedure. It is imperative that the
physician carefully weigh the risks and benefits of treatment versus non-treatment in contraindicated
patients:
•
Pregnancy
•
Gross invasive carcinoma of the cervix
•
A bleeding disorder
•
Acute or active inflammation of the cervix, endometrium, fallopian tube, ovary or peritoneum
(cervicitis, endometritis, tubo-ovarian inflammatory disease or pelvic inflammatory disease)
•
"Positive" endocervical curettage or a lesion in which the endocervical limit cannot be visualized
colposcopically
•
Less than three months postpartum
•
Equivocal cervical abnormality
5.4 LEEP Procedure and Technique
It is recommended that the patient be provided with a brief description of the procedure and the equipment
that will be used (ACOG, CooperSurgical and other professional organizations and equipment manufacturers
have produced patient information brochures on the LEEP procedure that address many of the questions and
concerns that your patients may have regarding the procedure).
5.5 Safety Precautions
1. This equipment should only be used by a thoroughly trained physician in an adequately equipped
medical facility.
2. Replacement accessories and patient return pads should be kept on hand since defective active
accessory or patient return pads can result in substandard performance of this equipment.
3. This equipment should only be connected to a properly grounded receptacle. NEVER use an adapter
that defeats the ground of the built-in three (3) prong plug.
4. Care must be exercised when handling liquids around electrical equipment. DO NOT attempt to
operate this equipment if liquids have spilled on the Electrosurgical Generator. DO NOT use
flammable liquids around electrical equipment.
5. This equipment should never be used in conjunction with other equipment for which safety against
leakage current has not been established.
14
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LEEP System 1000
Workstation • Model KH1000A • Operating Manual • English
(continued)