LLETZ Under General Versus Local Anesthesia
Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
1 other identifier
interventional
229
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
April 3, 2018
CompletedStudy Start
First participant enrolled
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2020
CompletedMarch 23, 2020
March 1, 2020
1.9 years
April 3, 2018
March 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 hours
Secondary Outcomes (10)
Postoperative pain
2 hours
the resected cone mass
10 minutes
Operation time
20 minutes
Operative complications
14 days
Time to complete intraoperative hemostasis
120 seconds
- +5 more secondary outcomes
Study Arms (2)
LLETZ under local anaesthesia
EXPERIMENTALThe LLETZ procedure will be performed under local anaesthesia
LLETZ under general anaesthesia
ACTIVE COMPARATORThe LLETZ procedure will be performed under general anaesthesia
Interventions
Conization will be performed under local anaesthesia
Conization will be performed under general anaesthesia
Eligibility Criteria
You may qualify if:
- colposcopy Prior to conization
- informed consent
- histologically proven high grade cervical dysplasia
- Transformation zone typ 1 or 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (1)
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.
PMID: 32585223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, M.D.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 11, 2018
Study Start
April 3, 2018
Primary Completion
February 28, 2020
Study Completion
March 14, 2020
Last Updated
March 23, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share