Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
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.
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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Abdominal Hysterectomy for Benign Disease
Intervention
Plasmakinetic bipolar energy forceps, Abdominal Hysterectomy with traditional suture technique
Location
Hospital Central Norte
Distrito Federal
Mexico
Status
Completed
Source
Hospital de Concentracion Norte de Petroleos
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00654849
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Bioelectric Energy Sources
Electric power supply devices which convert biological energy, such as chemical energy of metabolism or mechanical energy of periodic movements, into electrical energy.
Fibromatosis, Aggressive
A childhood counterpart of abdominal or extra-abdominal desmoid tumors, characterized by firm subcutaneous nodules that grow rapidly in any part of the body but do not metastasize. The adult form of abdominal fibromatosis is FIBROMATOSIS, ABDOMINAL. (Stedman, 25th ed)
Abdominal Fat
Fatty tissue in the region of the ABDOMEN. It includes the ABDOMINAL SUBCUTANEOUS FAT and the INTRA-ABDOMINAL FAT.
Energy Transfer
The transfer of energy of a given form among different scales of motion. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed). It includes the transfer of kinetic energy and the transfer of chemical energy. The transfer of chemical energy from one molecule to another depends on proximity of molecules so it is often used as in techniques to measure distance such as the use of FORSTER RESONANCE ENERGY TRANSFER.
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