Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy
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.
Indications for Laparoscopic Supracervical Hysterectomy
Device: Sealing tissue with the Enseal device
Procedure: Conventional supracervical hysterectomy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure|
- Operation time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay.
|Study Start Date:||August 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806012
|University Women' Clinic Tübingen|
|Tübingen, Germany, 72076|