Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial - Full Text View

Purpose

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.

Condition	Intervention
Abdominal Hysterectomy for Benign Disease	Procedure: Plasmakinetic bipolar energy forceps Procedure: Abdominal Hysterectomy with traditional suture technique

MedlinePlus related topics:

Hysterectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Hospital de Concentracion Norte de Petroleos:

Primary Outcome Measures:

Blood loss measured by anesthesiology service during the procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Operating time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Length of stay [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The total cost of the procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	94
Study Start Date:	February 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing	Procedure: Plasmakinetic bipolar energy forceps Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
2: Active Comparator traditional abdominal hysterectomy technique with the use of sutures	Procedure: Abdominal Hysterectomy with traditional suture technique The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654849

Locations


Mexico
	Hospital Central Norte
	Distrito Federal, Mexico

Sponsors and Collaborators

Hospital de Concentracion Norte de Petroleos

Investigators


Principal Investigator:	Carlos H Briones, MD	Servicios Medicos de Petroleos Mexicanos

More Information

General information about the plasmakinetic forceps This link exits the ClinicalTrials.gov site

Publications:

Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990-1997. Obstet Gynecol. 2002 Feb;99(2):229-34.

Broder MS, Kanouse DE, Mittman BS, Bernstein SJ. The appropriateness of recommendations for hysterectomy. Obstet Gynecol. 2000 Feb;95(2):199-205.

Presthus JB, Brooks PG, Kirchhof N. Vessel sealing using a pulsed bipolar system and open forceps. J Am Assoc Gynecol Laparosc. 2003 Nov;10(4):528-33.

Hagen B, Eriksson N, Sundset M. Randomised controlled trial of LigaSure versus conventional suture ligature for abdominal hysterectomy. BJOG. 2005 Jul;112(7):968-70.

Dessole S, Rubattu G, Capobianco G, Caredda S, Cherchi PL. Utility of bipolar electrocautery scissors for abdominal hysterectomy. Am J Obstet Gynecol. 2000 Aug;183(2):396-9.

Responsible Party:	Servicios de Salud Petroleos Mexicanos ( Carlos Humberto Briones Landa MD )
Study ID Numbers:	PKHTA2007, PKHTA12345
First Received:	April 2, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00654849
Health Authority:	Mexico: Ethics Committee

Keywords provided by Hospital de Concentracion Norte de Petroleos:

Electrosurgery

Gyrus Pk

abdominal hysterectomy

Blood Loss, Surgical

Length of stay

Overall cost

Study placed in the following topic categories:

Blood Loss, Surgical

Hemorrhage

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Hospital de Concentracion Norte de Petroleos
Information provided by:	Hospital de Concentracion Norte de Petroleos
ClinicalTrials.gov Identifier:	NCT00654849