Clinical trial NCT00654849: Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
Official title: Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Hysterectomy for Benign Disease
Keywords: Electrosurgery
Gyrus Pk
abdominal hysterectomy
Blood Loss, Surgical
Length of stay
Overall cost
Lead sponsor: Hospital de Concentracion Norte de Petroleos
Sponsor class: OTHER_GOV
First posted: 2008-04-09
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Blood loss measured by anesthesiology service during the procedure
timeFrame: 1 year
Secondary outcomes:
measure: Operating time
timeFrame: 1 year
measure: Length of stay
timeFrame: 1 year
measure: The total cost of the procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Distrito Federal
country: Mexico
facility: Hospital Central Norte
Study officials:
affiliation: Servicios Medicos de Petroleos Mexicanos
name: Carlos H Briones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990-1997. Obstet Gynecol. 2002 Feb;99(2):229-34. doi: 10.1016/s0029-7844(01)01723-9.
citation: Broder MS, Kanouse DE, Mittman BS, Bernstein SJ. The appropriateness of recommendations for hysterectomy. Obstet Gynecol. 2000 Feb;95(2):199-205. doi: 10.1016/s0029-7844(99)00519-0.
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. doi: 10.1016/s1074-3804(05)60161-2.
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. doi: 10.1111/j.1471-0528.2005.00561.x.
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. doi: 10.1067/mob.2000.105911.
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.