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LLETZ Under General Versus Local Anesthesia

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ClinicalTrials.gov Identifier: NCT03494686
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Zydolab - Institute of Cytology and Immune Cytochemistry

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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Dysplasia Procedure: LLETZ under local anaesthesia Procedure: LLETZ under general anaesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : March 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LLETZ under local anaesthesia
The LLETZ procedure will be performed under local anaesthesia
Procedure: LLETZ under local anaesthesia
Conization will be performed under local anaesthesia

Active Comparator: LLETZ under general anaesthesia
The LLETZ procedure will be performed under general anaesthesia
Procedure: LLETZ under general anaesthesia
Conization will be performed under general anaesthesia




Primary Outcome Measures :
  1. Womens satisfaction [ Time Frame: 2 hours ]
    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 :
  1. Postoperative pain [ Time Frame: 2 hours ]
    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

  2. the resected cone mass [ Time Frame: 10 minutes ]
    the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

  3. Operation time [ Time Frame: 20 minutes ]
    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

  4. Operative complications [ Time Frame: 14 days ]
    Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

  5. Time to complete intraoperative hemostasis [ Time Frame: 120 seconds ]
    the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

  6. Surgeons satisfaction [ Time Frame: 20 minutes ]
    Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment

  7. number of fragments of the surgical specimen [ Time Frame: 20 minutes ]
    surgeons will count the number of the surgical specimen (1 vs. >1)

  8. the dimensions of the surgical specimens [ Time Frame: 20 minutes ]
    The circumference, length and thickness of The surgical specimens will be measured

  9. Intraoperative blood loss [ Time Frame: 5 hours ]
    intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

  10. Margin status [ Time Frame: 2 days after conization ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494686


Locations
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Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, NRW, Germany, 44625
Sponsors and Collaborators
Zydolab - Institute of Cytology and Immune Cytochemistry
Investigators
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Principal Investigator: Ziad Hilal, M.D. Zydolab - Institute of Cytology and Immune Cytochemistry
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Responsible Party: Zydolab - Institute of Cytology and Immune Cytochemistry
ClinicalTrials.gov Identifier: NCT03494686    
Other Study ID Numbers: CONE-4
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zydolab - Institute of Cytology and Immune Cytochemistry:
conization
LLETZ
randomized controlled trial
loop excision
general anaesthesia
local anaesthesia
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs