Clinical trial · Interventional
Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy
Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure
NCT01806012CI-TRIAL-00009655completedN/AClinicalTrials.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)
The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.
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 |
|---|---|---|---|
| Indications for Laparoscopic Supracervical Hysterectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional supracervical hysterectomy | Procedure | — | UNRESOLVED |
| Sealing tissue with the Enseal device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enseal
- description
- Tissue sealing with Enseal device
- interventionNames
- Device: Sealing tissue with the Enseal device
- type
- ACTIVE_COMPARATOR
- label
- Supracervical hysterectomy using conventional instruments
- description
- Supracervical hysterectomy using conventional instruments
- interventionNames
- Procedure: Conventional supracervical hysterectomy
Primary outcomes (1)
- measure
- Operation time
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy) * Willingness and capability to comply with all study tests, procedures, and assessment tools * Capability of providing informed consent. Exclusion Criteria: * History of, or evidence of, gynecologic malignancy within the past five years * Pace maker, internal defibrilator/cardioconverter * Impaired coagulation parameters * Unwillingness to be randomized to treatment * History of median laparotomy * Intraabdominal adhesions * Requirement for open laparoscopy
References
Publications (2)
- DERIVEDRothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20. PMID 23791399
- DERIVEDRothmund R, Szyrach M, Reda A, Enderle MD, Neugebauer A, Taran FA, Brucker S, Hausch A, Wallwiener C, Kraemer B. A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy. Surg Endosc. 2013 Oct;27(10):3852-9. doi: 10.1007/s00464-013-2994-4. Epub 2013 May 14. PMID 23670744