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

Not Applicable

Completed

• Conditions: Uterine Bleeding Disorders; Benign Uterine Conditions; Focus: Comparison of Two Instruments
• Interventions: Device: BiCision®; Device: Ultracision® Har-monic Scalpel(Ethicon)

• Registration Number: NCT01752725
• Lead Sponsor: University Hospital Tuebingen

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-14
• Last Update Submitted: 2012-12-14
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiCision Arm	BiCision®	Coagulation with BiCision
Ultracision Arm	Ultracision® Har-monic Scalpel(Ethicon)	Coagulation with Ultracision

Primary Outcome Measures

Name	Time	Method
Operation time	Participants will be followed for the duration of hospital stay, an expexted average of 8 months	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.

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Tübingen, Germany