Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy
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|ClinicalTrials.gov Identifier: NCT01806012|
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Indications for Laparoscopic Supracervical Hysterectomy||Device: Sealing tissue with the Enseal device Procedure: Conventional supracervical hysterectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Tissue sealing with Enseal device
Device: Sealing tissue with the Enseal device
Active Comparator: Supracervical hysterectomy using conventional instruments
Supracervical hysterectomy using conventional instruments
Procedure: Conventional supracervical hysterectomy
- Operation time [ Time Frame: Day 1 ]The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure.
- Blood loss [ Time Frame: Day 2 ]The perioperative blood loss (ΔHb) was calculated using the comparison of the preoperative red blood cells (RBC) versus the RBC on the first post-operative day. The intraoperative blood loss was measured by the suction unit (categories: < 50 ml, 50 - 100 ml, > 100 ml) and by the number of applied blood transfusions.
- Post-operative pain [ Time Frame: Day 2 ]Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806012
|University Women' Clinic Tübingen|
|Tübingen, Germany, 72076|