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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00654849
Acronym
PKAHRCT
Enrollment
94
Registered
2008-04-09
Start date
2007-02-28
Completion date
2008-02-29
Last updated
2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Hysterectomy for Benign Disease

Keywords

Electrosurgery, Gyrus Pk, abdominal hysterectomy, Blood Loss, Surgical, Length of stay, Overall cost

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.

Interventions

PROCEDUREPlasmakinetic bipolar energy forceps

Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy

PROCEDUREAbdominal Hysterectomy with traditional suture technique

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

Sponsors

Hospital de Concentracion Norte de Petroleos
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood loss measured by anesthesiology service during the procedure1 year

Secondary

MeasureTime frame
Operating time1 year
Length of stay1 year
The total cost of the procedure1 year

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026