An interventional study of LLETZ under local anaesthesia and LLETZ under general anaesthesia 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 2020-03-23.
Sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry · Not applicable, Interventional, and Treatment
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.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 229 is above 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.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
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.
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.
The LLETZ procedure will be performed under local anaesthesia
Procedure: LLETZ under local anaesthesia
The LLETZ procedure will be performed under general anaesthesia
Procedure: LLETZ under general anaesthesia
Conization will be performed under local anaesthesia
Conization will be performed under general anaesthesia
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
Time frame: 2 hours
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
Time frame: 2 hours
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
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
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
Surgeons satisfaction
Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment
Time frame: 20 minutes
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. \>1)
Time frame: 20 minutes
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
Time frame: 20 minutes
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
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
Plan to share: No
Ran from Apr 2018 to primary completion in Feb 2020, 22 months.
Of 77 non-industry interventional studies with no phase under Uterine Cervical Dysplasia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 22 months is close to that.
Counting every sponsor, half of 81 studies reached it within 26 months; a quarter within 13 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Zydolab - Institute of Cytology and Immune Cytochemistry