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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Hysterectomy for Benign Disease

Intervention / Treatment
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* Procedure: Plasmakinetic bipolar energy forceps
* Procedure: Abdominal Hysterectomy with traditional suture technique


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing | Procedure: Plasmakinetic bipolar energy forceps<br>* Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy<br>* Other names: Gyrus PK 3103PK;|
| Active Comparator: 2<br>traditional abdominal hysterectomy technique with the use of sutures | Procedure: Abdominal Hysterectomy with traditional suture technique<br>* The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.<br>* Other names: Traditional technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss measured by anesthesiology service during the procedure |  | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrosurgery, Gyrus Pk, abdominal hysterectomy, Blood Loss, Surgical, Length of stay, Overall cost