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

Abdominal Hysterectomy for Benign Disease Clinical Trial

— PKAHRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654849
• Other study ID #: PKHTA2007
• Secondary ID: PKHTA12345
• Status: Completed
• Phase: N/A
• First received: April 2, 2008
• Last updated: April 21, 2008
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Hospital de Concentracion Norte de Petroleos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Hysterectomy for Benign Disease

Intervention

Procedure:
• Plasmakinetic bipolar energy forceps
Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
• Abdominal Hysterectomy with traditional suture technique
The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.

Locations

Country	Name	City	State
Mexico	Hospital Central Norte	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Concentracion Norte de Petroleos

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Rock J.,Howards WJ. Histerectomía em: Te Linde Ginecologia Quirúrgica .9ed,Editorial Panamericana Argentina 2006 (31):875-896. Uterine Surgery, En Nezhat C., Nezhat F., Luciano A., et al, eds., operative Gynecologic Laparoscopy; 1ª Ed: New York, New York; McGraw Hill, Inc.: 1995; 216-38. Hernández-Denis A. Audifred-Salomón J. Aspectos Generales en Endoscopia. En Hernández-Denis A. Audifred-Salomón J. Manual de Endoscopica en Ginecología. México; 2005:5-23.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss measured by anesthesiology service during the procedure		1 year	Yes
Secondary	Operating time		1 year	Yes
Secondary	Length of stay		1 year	Yes
Secondary	The total cost of the procedure		1 year	Yes