Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial (CONE-1)

In a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray versus forced coagulation, will be compared. The primary outcome of the study is time to complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain, and postoperative bleeding complications.

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Dysplasia
• Intervention / Treatment: Procedure: Spray; Procedure: Forced

Detailed Description

Intraoperative bleeding during large loop excision of the transformation zone (LLETZ)-conization can be achieved by two modes of electrocoagulation, spray coagulation and forced coagulation. Spray coagulation is a superficial coagulation mode, whereas forced coagulation is a deep tissue coagulation mode. It is unknown, whether spray or forced coagulation is superior regarding intraoperative hemostasis and other outcome Parameters such as postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, comparing the two coagulation modes, spray coagulation and forced coagulation, The primary outcome of the study is time to complete hemostasis measured in seconds, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 10 step VAS scale, and postoperative bleeding complications, defined as necessity to intervene surgically for vaginal bleeding up to 14 days postoperatively. The study Population consists of women undergoing LLETZ-conization for histologically proven cervical dysplasia. The study hypothesis states that the difference in the mean time until complete hemostais will be at least 1/3 shorter in women randomized to spray coagulation. With a study Population of 120 women, this study has a power of >80% to detect a difference of 1/3 of the mean coagulation time until complete hemostais based on an anticipated mean time of 85 seconds.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44625
    • Ruhr University Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• histologically proven cervical dysplasia
• colposcopy Prior to LLETZ-conization
• informed consent
• no known hematologic disorder

Exclusion Criteria:

• significant language barrier
• a personal history of LLETZ-conization

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: Spray; cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation	Procedure: Spray; surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage
Active Comparator: Forced; cervical coagulation using a deep tissue electrical coagulation mode, ie forced coagulation	Procedure: Forced; surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	patients will score their postoperative pain Level using a 10-step visual analogue scale (VAS) within 5 hours after surgery	5 hours
postoperative complications	postoperative complications defined as the necessity to intervene surgically for vaginal bleeding within 14 days after surgery	14 days
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Clemens B Tempfer, MD, Ruhr University Bochum

Publications and helpful links

General Publications

• Hilal Z, Mavrommati G, Foerster C, Rezniczek GA, Hefler LA, Tempfer CB. Spray Versus Forced Coagulation in Large Loop Excision of the Transformation Zone: A Randomized Trial. J Low Genit Tract Dis. 2016 Apr;20(2):169-73. doi: 10.1097/LGT.0000000000000177.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 27, 2014
• First Submitted That Met QC Criteria: December 31, 2014
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: cervical dysplasia; conization; LLETZ; cervical intraepithelial neoplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Hyperplasia; Uterine Cervical Dysplasia
• Other Study ID Numbers: CONE-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No