LLETZ Under General Versus Local Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Dysplasia
• Intervention / Treatment: Procedure: LLETZ under local anaesthesia; Procedure: LLETZ under general anaesthesia

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Herne, NRW, Germany, 44625
      • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Operative complications	Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively	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	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	5 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	2 hours
Surgeons satisfaction	Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment	20 minutes
number of fragments of the surgical specimen	surgeons will count the number of the surgical specimen (1 vs. >1)	20 minutes
the dimensions of the surgical specimens	The circumference, length and thickness of The surgical specimens will be measured	20 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	2 days after conization

Collaborators and Investigators

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Publications and helpful links

General Publications

• Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 14, 2020

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: general anaesthesia; randomized controlled trial; conization; LLETZ; loop excision; local anaesthesia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CONE-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No