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

April 21, 2008 updated by: Hospital de Concentracion Norte de Petroleos

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Distrito Federal, Mexico
        • Hospital Central Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Traditional technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood loss measured by anesthesiology service during the procedure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Operating time
Time Frame: 1 year
1 year
Length of stay
Time Frame: 1 year
1 year
The total cost of the procedure
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Concentracion Norte de Petroleos

Investigators

  • Principal Investigator: Carlos H Briones, MD, Servicios Medicos de Petroleos Mexicanos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKHTA2007
  • PKHTA12345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Hysterectomy for Benign Disease

Clinical Trials on Plasmakinetic bipolar energy forceps

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe