Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source Centre Hospitalier Universitaire, Amiens
Brief 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.

Detailed 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.

Overall Status Completed
Start Date January 1, 2015
Completion Date January 1, 2017
Primary Completion Date January 1, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Impact of anaesthesia on height of resection specimens. 1 year
Enrollment 107
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- every patient who underwent a first conization procedure

- regardless of indication

Exclusion Criteria:

- patient's refusal to participate.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jean Gondry, MD, PhD Principal Investigator CHU AMIENS
Verification Date

September 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Acronym LEEP-DIM
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Retrospective

Source: ClinicalTrials.gov