Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial (PKAHRCT)
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|ClinicalTrials.gov Identifier: NCT00654849|
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 22, 2008
Objective: To compare the safety and efficacy of the use of bipolar plasmakinetic vessel sealing (Gyrus Pk) usage versus standard technique when performing total abdominal hysterectomy for benign disease.
Material and Methods: controlled randomized trial involving 94 women who underwent total abdominal hysterectomy. 47 procedures were performed using bipolar plasmakinetic vessel sealing and the remaining 47 with the standard sutures technique. The primary outcomes were improvement in terms of blood loss, procedure time, length of hospital stay, and overall cost of the procedure. Statistical methodology considered significant P <0.05.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Hysterectomy for Benign Disease||Procedure: Plasmakinetic bipolar energy forceps Procedure: Abdominal Hysterectomy with traditional suture technique||Not Applicable|
All patients were right-holders of the Petroleos Mexicanos (Mexican oil company) medical network who required hysterectomy surgical treatment for benign causes All patients included in the study signed an informed consent form, knowing all possible implications of the procedure Patients were randomly assigned to one of the two techniques: 1. plasmakinetic bipolar energy forceps (Gyrus PK) and 2. Standard technique using sutures The surgical steps other than placement of suture are identical to those used during standard abdominal hysterectomy. Time of the procedure was considered from the moment skin was first cut-open, until it was fully closed, previously checking satisfactory homeostasis.
Blood loss was estimated by the anesthesiology service. Further data compiled included time spent in hospital and the total cost of the procedure.
Post-surgery complications were recorded at the follow up visits one and 4 weeks after the surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing
Procedure: Plasmakinetic bipolar energy forceps
Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
Other Name: Gyrus PK 3103PK
Active Comparator: 2
traditional abdominal hysterectomy technique with the use of sutures
Procedure: Abdominal Hysterectomy with traditional suture technique
The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.
Other Name: Traditional technique
- Blood loss measured by anesthesiology service during the procedure [ Time Frame: 1 year ]
- Operating time [ Time Frame: 1 year ]
- Length of stay [ Time Frame: 1 year ]
- The total cost of the procedure [ Time Frame: 1 year ]
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): NCT00654849
|Hospital Central Norte|
|Distrito Federal, Mexico|
|Principal Investigator:||Carlos H Briones, MD||Servicios Medicos de Petroleos Mexicanos|