An interventional study of LLETZ with colposcopy and LLETZ without colposcopy in Uterine Cervical Dysplasia, sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry · Not applicable, Interventional, and Treatment
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 150 is below the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Zydolab - Institute of Cytology and Immune Cytochemistry is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The LLETZ procedure will be performed under direct colposcopic vision
Device: LLETZ with colposcopy
The LLETZ procedure will be performed without colposcopy
Other: LLETZ without colposcopy
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
Loop procedure without using a colposcope
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
Time frame: 10 minutes
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
Time frame: 2 Days after conization
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
Time frame: 20 minutes
Operative complications
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Time frame: 14 days
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. \>1)
Time frame: 10 minutes
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
Time frame: 2 Days after conization
handling of the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')
Time frame: 30 minutes
satisfaction with the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')
Time frame: 30 minutes
Time to complete intraoperative hemostasis
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Time frame: 120 seconds
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
Time frame: 5 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Zydolab - Institute of Cytology and Immune Cytochemistry