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Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial (PKAHRCT)
This study has been completed.
Study NCT00654849   Information provided by Hospital de Concentracion Norte de Petroleos
First Received: April 2, 2008   Last Updated: April 21, 2008   History of Changes

April 2, 2008
April 21, 2008
February 2007
February 2008   (final data collection date for primary outcome measure)
Blood loss measured by anesthesiology service during the procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00654849 on ClinicalTrials.gov Archive Site
  • Operating time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The total cost of the procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
 
Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Abdominal Hysterectomy for Benign Disease
  • Procedure: Plasmakinetic bipolar energy forceps
  • Procedure: Abdominal Hysterectomy with traditional suture technique
  • Experimental: compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing
  • Active Comparator: traditional abdominal hysterectomy technique with the use of sutures

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
94
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patient with a benign disease as indication for hysterectomy

Exclusion Criteria:

  • Hysterectomy for malignant pathology
  • Laparoscopic or vaginal hysterectomy
  • Any patient in which the procedure used both techniques
  • Obstetric hysterectomy
Female
 
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00654849
Carlos Humberto Briones Landa MD, Servicios de Salud Petroleos Mexicanos
PKHTA2007, PKHTA12345
Hospital de Concentracion Norte de Petroleos
 
Principal Investigator: Carlos H Briones, MD Servicios Medicos de Petroleos Mexicanos
Hospital de Concentracion Norte de Petroleos
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP