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.
Exclusion Criteria:
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
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zydolab - Institute of Cytology and Immune Cytochemistry