LLETZ Under General Versus Local Anesthesia

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Procedure: LLETZ under general anaesthesia; Procedure: LLETZ under local anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03494686

CONE-4

Details and patient eligibility

About

The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

Enrollment: 229 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• colposcopy Prior to conization
• informed consent
• histologically proven high grade cervical dysplasia
• Transformation zone typ 1 or 2

Exclusion criteria

• significant language barrier
• a personal history of conization
• pregnancy
• the use of blood thinner
• unwillingness to participate
• oncological disease
• inpatient treatment
• women who are not fasting
• risk of aspiration
• columnar-squamous epithelium border not fully visible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 2 patient groups

LLETZ under local anaesthesia

Experimental group

Description:

The LLETZ procedure will be performed under local anaesthesia

Treatment:

Procedure: LLETZ under local anaesthesia

LLETZ under general anaesthesia

Active Comparator group

Description:

The LLETZ procedure will be performed under general anaesthesia

Treatment:

Procedure: LLETZ under general anaesthesia