Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

NCT ID: NCT03737526

Last Updated: 2023-05-17

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

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-01-01

Brief Summary

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To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).

Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Detailed Description

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Measure of conization specimens can be done in the operating theatre on fresh specimen or by pathologist after fixation. Methods and conditions of specimen measurement are rarely, if ever, described in published studies.

To study the influence of anaesthesia (local by cervical block vs. general or spinal anaesthesia) on height and volume of resection specimens in case of conization treatment for cervical intraepithelial neoplasia (CIN).

Prospective observational study of all patients who underwent a first treatment by loop electrosurgical excision procedure (LEEP) for CIN. Height of fresh resection specimens was first measured by the operator and then by the pathologist after formaldehyde fixation. Volume of fresh specimens was measured in a measuring cylinder by fluid displacement.

Conditions

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Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* every patient who underwent a first conization procedure
* regardless of indication

Exclusion Criteria

* patient's refusal to participate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Gondry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Other Identifiers

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PI2017_843_0050

Identifier Type: -

Identifier Source: org_study_id

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