Skip to main content
OpenTrials
Completed

NCT Number: NCT00654849

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Hysterectomy for Benign Disease Blood Loss, Surgical Body Temperature Changes Heat Stress Disorders Hemorrhage Hyperthermia Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Central Norte

Distrito Federal, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmakinetic bipolar energy forceps

Procedure

Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy

Other names: Gyrus PK 3103PK

Abdominal Hysterectomy with traditional suture technique

Procedure

The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.

Other names: Traditional technique

Primary outcomes

  1. Blood loss measured by anesthesiology service during the procedure

    Time frame: 1 year

Secondary outcomes

  1. Operating time

    Time frame: 1 year

  2. Length of stay

    Time frame: 1 year

  3. The total cost of the procedure

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hospital de Concentracion Norte de Petroleos

Other Gov

Registry information

Acronym: PKAHRCT

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Apr 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.