LLETZ Under General Versus Local Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2020-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LLETZ under local anaesthesia

The LLETZ procedure will be performed under local anaesthesia

Group Type EXPERIMENTAL

LLETZ under local anaesthesia

Intervention Type PROCEDURE

Conization will be performed under local anaesthesia

LLETZ under general anaesthesia

The LLETZ procedure will be performed under general anaesthesia

Group Type ACTIVE_COMPARATOR

LLETZ under general anaesthesia

Intervention Type PROCEDURE

Conization will be performed under general anaesthesia

Interventions

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LLETZ under local anaesthesia

Conization will be performed under local anaesthesia

Intervention Type PROCEDURE

LLETZ under general anaesthesia

Conization will be performed under general anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No