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

NCT ID: NCT02330471

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

Brief 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.

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.

Conditions

Uterine Cervical Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spray

cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation

Group Type: EXPERIMENTAL

Spray

Intervention Type: PROCEDURE

surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage

Forced

cervical coagulation using a deep tissue electrical coagulation mode, ie forced coagulation

Group Type: ACTIVE_COMPARATOR

Forced

Intervention Type: PROCEDURE

surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage

Interventions

Spray

surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage

Intervention Type: PROCEDURE

Forced

surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Clemens Tempfer

Clemens Tempfer, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clemens B Tempfer, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

Ruhr University Bochum

Bochum, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 26796660 (View on PubMed)

Other Identifiers

CONE-1

Identifier Type: -

Identifier Source: org_study_id