LLETZ Under General Versus Local Anesthesia

Uterine Cervical Dysplasia Clinical Trial

Official title:

Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494686
• Other study ID #: CONE-4
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: March 14, 2020

Study information

• Verified date: March 2020
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: March 14, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Procedure:
• LLETZ under local anaesthesia
Conization will be performed under local anaesthesia
• LLETZ under general anaesthesia
Conization will be performed under general anaesthesia

Locations

Country	Name	City	State
Germany	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 hours
Secondary	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	10 minutes
Secondary	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	20 minutes
Secondary	Operative complications	Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively	14 days
Secondary	Time to complete intraoperative hemostasis	the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds	120 seconds
Secondary	Surgeons satisfaction	Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment	20 minutes
Secondary	number of fragments of the surgical specimen	surgeons will count the number of the surgical specimen (1 vs. >1)	20 minutes
Secondary	the dimensions of the surgical specimens	The circumference, length and thickness of The surgical specimens will be measured	20 minutes
Secondary	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	5 hours
Secondary	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	2 days after conization