Clinical trial · Interventional
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial
NCT02330471CI-TRIAL-00059547CONE-1completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Forced | Procedure | — | UNRESOLVED |
| Spray | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Spray
- description
- cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation
- interventionNames
- Procedure: Spray
- type
- ACTIVE_COMPARATOR
- label
- Forced
- description
- cervical coagulation using a deep tissue electrical coagulation mode, ie forced coagulation
- interventionNames
- Procedure: Forced
Primary outcomes (1)
- measure
- time to complete intraoperative hemostasis
- timeFrame
- 120 seconds
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHilal 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 26796660