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

Benign Uterine Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752725
• Other study ID #: 04122012
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 14, 2012
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: December 2012
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Uterine Conditions
• Blood Coagulation Disorders
• Focus: Comparison of Two Instruments
• Hemostatic Disorders
• Uterine Bleeding Disorders
• Uterine Hemorrhage

Intervention

Device:
• BiCision®

• Ultracision® Har-monic Scalpel(Ethicon)

Locations

Country	Name	City	State
Germany	University Hospital	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	ERBE Elektromedizin GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No