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NCT03737526 Clinical Trial

Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Anesthesia Clinical Trial

— LEEP-DIM  

Official title:
Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03737526
Other study ID # PI2017_843_0050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date January 1, 2017

Study information
Verified date May 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date January 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - every patient who underwent a first conization procedure - regardless of indication Exclusion Criteria: - patient's refusal to participate.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of anaesthesia on height of resection specimens. evaluate the impact of the excision procedure technique by the mode of anesthesia using the loop electrosurgical on height of resection specimens in case of conization treatment for cervical intraepithelial neoplasia. 1 year
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