Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH)

Study Overview
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Brief Summary
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The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified thermofu-sion and dissection instrument BiCision® in comparison with the long established Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy (LASH).

Official Title
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Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.

Conditions
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Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments

Intervention / Treatment
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* Device: BiCision®
* Device: Ultracision® Har-monic Scalpel(Ethicon)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 gender: female indication for laparoscopic supracervical hysterectomy with no adnexectomyor other surgery will and the capability to comply the study requirements signed informed consent Exclusion Criteria: Invasive malignome in the pelvis Cardiac pacemaker or implanted defibrilator if no informations are available about the compatibil-ity with RF energy Abnormal blood parameters (values less than factor 0.8 or more than 1.25 compared to the val-ues of creatinine and standard hemogram) Abnormal coagulation parameters: PTT > 40 sec. and / or Quick's-Value< 50% (the use of antiplateletsup to a max. of 100mg/d is no exclusion criteria) Inability to understand the purpose of the study status after a laparotomy by a longitudinal incision intraabdominal adhesions (at the beginning of the surgery ≥ 5 sectioning for adhesiolysis) open laparoscopy required different anatomical situations that yields to different surgery requirements conspicuous PAP, cervixmyoma or endometriosis of the rectovaginale space

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiCision Arm<br>Coagulation with BiCision | Device: BiCision®<br> <br> |
| Active Comparator: Ultracision Arm<br>Coagulation with Ultracision | Device: Ultracision® Har-monic Scalpel(Ethicon)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | The primary objective is the operation time for each preparation side and instrument needed from the beginning of the removal of the cornual structure of the uterus (uterine cornu) till the completely removal of the parametric tissue directly before removal of the corpus uteri from the cervix. | Participants will be followed for the duration of hospital stay, an expexted average of 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supracervical hysterectomy, vessel sealing, bipolar electrocoagulation