Impact of Anaesthesia Mode on Evaluation of LEEP Specimen Dimensions
LEEP-DIM
1 other identifier
observational
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedJune 16, 2026
June 1, 2026
2 years
September 17, 2018
June 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
The investigators conducted a prospective non-randomized controlled study at the Amiens University Hospital (France). The study took place between January and December 2015. The investigators included every patient who underwent a first conization procedure, regardless of indication. The only exclusion criterion was the patient's refusal to participate.Written consent was obtained before procedure. Data was gathered using questionnaires, pre-, per- and post-procedure.
You may qualify if:
- every patient who underwent a first conization procedure
- regardless of indication
You may not qualify if:
- patient's refusal to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens-Picardie
Amiens, 80054, France
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Gondry, PU-PH
CHU AMIENS
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2018
First Posted
November 9, 2018
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
June 16, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share