MedTrace Logo

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

NCT00654849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2008-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Hysterectomy for Benign Disease

Interventions

PROCEDURE

Plasmakinetic bipolar energy forceps

Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy

PROCEDURE

Abdominal Hysterectomy with traditional suture technique

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

Sponsors & Collaborators

  • Hospital de Concentracion Norte de Petroleos

    lead OTHER_GOV

Principal Investigators

  • Carlos H Briones, MD · Servicios Medicos de Petroleos Mexicanos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00654849 on ClinicalTrials.gov