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

Hospital de Concentracion Norte de Petroleos

Status: Completed

Conditions: Abdominal Hysterectomy for Benign Disease

Treatments: Procedure: Abdominal Hysterectomy with traditional suture technique; Procedure: Plasmakinetic bipolar energy forceps

Study type: Interventional

Funder types: Other

Identifiers

NCT00654849

PKHTA2007

PKHTA12345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

1

Experimental group

Description:

compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing

Treatment:

Procedure: Plasmakinetic bipolar energy forceps

2

Active Comparator group

Description:

traditional abdominal hysterectomy technique with the use of sutures

Treatment:

Procedure: Abdominal Hysterectomy with traditional suture technique