Abdominal Hysterectomy for Benign Disease Clinical Trial
Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|Source||Hospital de Concentracion Norte de Petroleos|
|Start date||February 2007|
|Completion date||February 2008|