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

Uterine Cervical Dysplasia Clinical Trial

— CONE-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330471
• Other study ID #: CONE-1
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Hyperplasia
• Uterine Cervical Dysplasia

Intervention

Procedure:
• Spray
surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage
• Forced
surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage

Locations

Country	Name	City	State
Germany	Ruhr University Bochum	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

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