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Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial (PKAHRCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654849
First Posted: April 9, 2008
Last Update Posted: April 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Concentracion Norte de Petroleos
  Purpose

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 Intervention
Abdominal Hysterectomy for Benign Disease Procedure: Plasmakinetic bipolar energy forceps Procedure: Abdominal Hysterectomy with traditional suture technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Concentracion Norte de Petroleos:

Primary Outcome Measures:
  • Blood loss measured by anesthesiology service during the procedure [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Operating time [ Time Frame: 1 year ]
  • Length of stay [ Time Frame: 1 year ]
  • The total cost of the procedure [ Time Frame: 1 year ]

Enrollment: 94
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Mexico
Hospital Central Norte
Distrito Federal, Mexico
Sponsors and Collaborators
Hospital de Concentracion Norte de Petroleos
Investigators
Principal Investigator: Carlos H Briones, MD Servicios Medicos de Petroleos Mexicanos
  More Information

Publications:
Responsible Party: Carlos Humberto Briones Landa MD, Servicios de Salud Petroleos Mexicanos
ClinicalTrials.gov Identifier: NCT00654849     History of Changes
Other Study ID Numbers: PKHTA2007
PKHTA12345
First Submitted: April 2, 2008
First Posted: April 9, 2008
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Hospital de Concentracion Norte de Petroleos:
Electrosurgery
Gyrus Pk
abdominal hysterectomy
Blood Loss, Surgical
Length of stay
Overall cost

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs