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

Not Applicable

Completed

• Conditions: Abdominal Hysterectomy for Benign Disease
• Interventions: Procedure: Plasmakinetic bipolar energy forceps; Procedure: Abdominal Hysterectomy with traditional suture technique

• Registration Number: NCT00654849
• Lead Sponsor: Hospital de Concentracion Norte de Petroleos

Brief 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.

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-04
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-09
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Plasmakinetic bipolar energy forceps	compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing
2	Abdominal Hysterectomy with traditional suture technique	traditional abdominal hysterectomy technique with the use of sutures

Primary Outcome Measures

Name	Time	Method
Blood loss measured by anesthesiology service during the procedure	1 year

Secondary Outcome Measures

Name	Time	Method
Operating time	1 year
Length of stay	1 year
The total cost of the procedure	1 year

Trial Locations

Locations (1)

Hospital Central Norte; 🇲🇽 Distrito Federal, Mexico