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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02330471
Other study ID # CONE-1
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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