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

NCT ID: NCT00654849

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Abdominal Hysterectomy for Benign Disease

Keywords

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Electrosurgery Gyrus Pk abdominal hysterectomy Blood Loss, Surgical Length of stay Overall cost

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing

Group Type EXPERIMENTAL

Plasmakinetic bipolar energy forceps

Intervention Type PROCEDURE

Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy

2

traditional abdominal hysterectomy technique with the use of sutures

Group Type ACTIVE_COMPARATOR

Abdominal Hysterectomy with traditional suture technique

Intervention Type PROCEDURE

The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.

Interventions

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Plasmakinetic bipolar energy forceps

Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy

Intervention Type PROCEDURE

Abdominal Hysterectomy with traditional suture technique

The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.

Intervention Type PROCEDURE

Other Intervention Names

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Gyrus PK 3103PK Traditional technique

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Concentracion Norte de Petroleos

OTHER_GOV

Sponsor Role lead

Responsible Party

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Servicios de Salud Petroleos Mexicanos

Principal Investigators

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Carlos H Briones, MD

Role: PRINCIPAL_INVESTIGATOR

Servicios Medicos de Petroleos Mexicanos

Locations

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Hospital Central Norte

Distrito Federal, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 11814502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10674580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14738643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15958001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10942476 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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PKHTA12345

Identifier Type: -

Identifier Source: secondary_id

PKHTA2007

Identifier Type: -

Identifier Source: org_study_id