LLETZ Under General Versus Local Anesthesia

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry (Other)
• Overall Status: Completed
• CT.gov ID: NCT03494686
• Collaborator: (none)
• Enrollment: 229
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.4
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 3, 2018
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Mar 14, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Womens satisfaction [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 [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 [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 [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 [14 days]

   Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

5. Time to complete intraoperative hemostasis [120 seconds]

   the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

6. Surgeons satisfaction [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 [20 minutes]

   surgeons will count the number of the surgical specimen (1 vs. >1)

8. the dimensions of the surgical specimens [20 minutes]

   The circumference, length and thickness of The surgical specimens will be measured

9. Intraoperative blood loss [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Ziad Hilal, M.D., Zydolab - Institute of Cytology and Immune Cytochemistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zydolab - Institute of Cytology and Immune Cytochemistry
• ClinicalTrials.gov Identifier: NCT03494686
• Other Study ID Numbers: CONE-4
• First Posted: Apr 11, 2018
• Last Update Posted: Mar 23, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Uterine Cervical Dysplasia; Cervical Intraepithelial Neoplasia; Anesthetics

Study Results

No Results Posted as of Mar 23, 2020