NCT03737526

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

September 17, 2018

Last Update Submit

June 15, 2026

Conditions

Keywords

loop electrosurgical excision procedure

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Study Officials

  • Jean Gondry, PU-PH

    CHU AMIENS

    PRINCIPAL INVESTIGATOR

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

Locations