NCT02330471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

December 27, 2014

Last Update Submit

July 7, 2022

Conditions

Uterine Cervical Dysplasia

Keywords

conizationLLETZcervical dysplasiacervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • postoperative pain

    5 hours

  • postoperative complications

    14 days

  • intraoperative blood loss

    5 hours

Study Arms (2)

Spray

EXPERIMENTAL

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

Procedure: Spray

Forced

ACTIVE COMPARATOR

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

Procedure: Forced

Interventions

SprayPROCEDURE

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

Spray
ForcedPROCEDURE

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

Forced

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhr University Bochum

Bochum, 44625, Germany

Location

Related 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.

    PMID: 26796660RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Clemens B Tempfer, MD

    Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clemens Tempfer, MD

Study Record Dates

First Submitted

December 27, 2014

First Posted

January 5, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

DE(1)