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LLETZ Under General Versus Local Anesthesia

Primary Purpose

Uterine Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LLETZ under local anaesthesia
LLETZ under general anaesthesia
Sponsored by
Zydolab - Institute of Cytology and Immune Cytochemistry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Dysplasia focused on measuring conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • colposcopy Prior to conization
  • informed consent
  • histologically proven high grade cervical dysplasia
  • Transformation zone typ 1 or 2

Exclusion Criteria:

  • significant language barrier
  • a personal history of conization
  • pregnancy
  • the use of blood thinner
  • unwillingness to participate
  • oncological disease
  • inpatient treatment
  • women who are not fasting
  • risk of aspiration
  • columnar-squamous epithelium border not fully visible

Sites / Locations

  • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LLETZ under local anaesthesia

LLETZ under general anaesthesia

Arm Description

The LLETZ procedure will be performed under local anaesthesia

The LLETZ procedure will be performed under general anaesthesia

Outcomes

Primary Outcome Measures

Womens satisfaction
Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment

Secondary Outcome Measures

Postoperative pain
patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery
the resected cone mass
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
Operation time
the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Operative complications
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Time to complete intraoperative hemostasis
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Surgeons satisfaction
Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. >1)
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
Intraoperative blood loss
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
Margin status
Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

Full Information

First Posted
April 3, 2018
Last Updated
March 19, 2020
Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
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1. Study Identification

Unique Protocol Identification Number
NCT03494686
Brief Title
LLETZ Under General Versus Local Anesthesia
Official Title
Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLETZ under local anaesthesia
Arm Type
Experimental
Arm Description
The LLETZ procedure will be performed under local anaesthesia
Arm Title
LLETZ under general anaesthesia
Arm Type
Active Comparator
Arm Description
The LLETZ procedure will be performed under general anaesthesia
Intervention Type
Procedure
Intervention Name(s)
LLETZ under local anaesthesia
Intervention Description
Conization will be performed under local anaesthesia
Intervention Type
Procedure
Intervention Name(s)
LLETZ under general anaesthesia
Intervention Description
Conization will be performed under general anaesthesia
Primary Outcome Measure Information:
Title
Womens satisfaction
Description
Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' ("not satisfied at all") to '10' ("very satisfied") 2 hours after Treatment
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' ("no pain" ) to '10' ("maximum pain") within 2 hours after surgery
Time Frame
2 hours
Title
the resected cone mass
Description
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
Time Frame
10 minutes
Title
Operation time
Description
the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Time Frame
20 minutes
Title
Operative complications
Description
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Time Frame
14 days
Title
Time to complete intraoperative hemostasis
Description
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Time Frame
120 seconds
Title
Surgeons satisfaction
Description
Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment
Time Frame
20 minutes
Title
number of fragments of the surgical specimen
Description
surgeons will count the number of the surgical specimen (1 vs. >1)
Time Frame
20 minutes
Title
the dimensions of the surgical specimens
Description
The circumference, length and thickness of The surgical specimens will be measured
Time Frame
20 minutes
Title
Intraoperative blood loss
Description
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
Time Frame
5 hours
Title
Margin status
Description
Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist
Time Frame
2 days after conization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: colposcopy Prior to conization informed consent histologically proven high grade cervical dysplasia Transformation zone typ 1 or 2 Exclusion Criteria: significant language barrier a personal history of conization pregnancy the use of blood thinner unwillingness to participate oncological disease inpatient treatment women who are not fasting risk of aspiration columnar-squamous epithelium border not fully visible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Hilal, M.D.
Organizational Affiliation
Zydolab - Institute of Cytology and Immune Cytochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology of the Ruhr University Bochum
City
Herne
State/Province
NRW
ZIP/Postal Code
44625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32585223
Citation
Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24.
Results Reference
derived

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LLETZ Under General Versus Local Anesthesia

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