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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Concentracion Norte de Petroleos
ClinicalTrials.gov Identifier:
NCT00654849
First received: April 2, 2008
Last updated: April 21, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
General information about the plasmakinetic forceps  This link exits the ClinicalTrials.gov site

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
Study First Received: April 2, 2008
Last Updated: April 21, 2008
Health Authority: Mexico: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013