Abdominal Hysterectomy for Benign DiseasePKAHRCTNCT00654849
Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
A study testing Plasmakinetic bipolar energy forceps and Abdominal Hysterectomy with traditional suture technique in people with Abdominal Hysterectomy for Benign Disease, run by Hospital de Concentracion Norte de Petroleos at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Abdominal Hysterectomy for Benign Disease
- What is being tested?
- Plasmakinetic bipolar energy forceps and Abdominal Hysterectomy with traditional suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with a benign disease as indication for hysterectomy
Who cannot join
- Hysterectomy for malignant pathology
- Laparoscopic or vaginal hysterectomy
- Any patient in which the procedure used both techniques
- Obstetric hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Plasmakinetic bipolar energy forceps, Abdominal Hysterectomy with traditional suture technique
- Keywords
- Electrosurgery, Gyrus Pk, abdominal hysterectomy, Blood Loss, Surgical, Length of stay, Overall cost
- Medical subject headings
- Hyperthermia, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmakinetic bipolar energy forcepsProcedure or surgery
Also called Gyrus PK 3103PK
Use of bipolar plasmakinetic vessel sealing during abdominal hysterectomy
Abdominal Hysterectomy with traditional suture techniqueProcedure or surgery
Also called Traditional technique
The abdominal hysterectomy was realized using sutures in the haemostasia of pedicles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | compare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing Receives: Procedure: Plasmakinetic bipolar energy forceps |
| 2 | Active comparator | traditional abdominal hysterectomy technique with the use of sutures Receives: Procedure: Abdominal Hysterectomy with traditional suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss measured by anesthesiology service during the procedure
Measured: 1 year
Secondary outcomes (3)
Operating time
Measured: 1 year
Length of stay
Measured: 1 year
The total cost of the procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdominal Hysterectomy for Benign DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Concentracion Norte de Petroleos
- Sponsor type
- Other government
- Investigators
- Carlos H Briones, MD, Principal investigator, Servicios Medicos de Petroleos Mexicanos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654849
- Sponsor's protocol ID
- PKHTA2007
- Other IDs
- PKHTA12345
- Acronym
- PKAHRCT
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11814502Broder 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.
PubMed 10674580Presthus 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.
PubMed 14738643Hagen 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.
PubMed 15958001Dessole 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.
PubMed 10942476Rock 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00654849
- Acronym / sponsor ID
- PKAHRCT / PKHTA2007
- Keywords
- Electrosurgery, Gyrus Pk, abdominal hysterectomy, Blood Loss, Surgical, Length of stay, Overall cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hospital de Concentracion Norte de PetroleosOther government
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Plasmakinetic bipolar energy forcepscompare security and effectiveness of use Electrosurgical Bipolar Plasmakinetic Vessel Sealing |
| 2 | Active comparator | Procedure: Abdominal Hysterectomy with traditional suture techniquetraditional abdominal hysterectomy technique with the use of sutures |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with a benign disease as indication for hysterectomy
Key exclusion criteria (4 listed)
- Hysterectomy for malignant pathology
- Laparoscopic or vaginal hysterectomy
- Any patient in which the procedure used both techniques
- Obstetric hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmakinetic bipolar energy forcepsAlso: Gyrus PK 3103PKUse of bipolar plasmakinetic vessel sealing during abdominal hysterectomy | Procedure or surgery | 1 |
| Abdominal Hysterectomy with traditional suture techniqueAlso: Traditional techniqueThe abdominal hysterectomy was realized using sutures in the haemostasia of pedicles. | Procedure or surgery | 2 |
Primary outcome
Blood loss measured by anesthesiology service during the procedure
Time frame: 1 year
3 secondary outcomes
Operating time
Time frame: 1 year
Length of stay
Time frame: 1 year
The total cost of the procedure
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
- Background: PubMed 11814502Farquhar 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.
- Background: PubMed 10674580Broder 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.
- Background: PubMed 14738643Presthus 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.
- Background: PubMed 15958001Hagen 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.
- Background: PubMed 10942476Dessole 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.
- BackgroundRock 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos H Briones, MD principal investigator
Servicios Medicos de Petroleos Mexicanos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmakinetic bipolar energy forceps and Abdominal Hysterectomy with traditional suture technique in people with Abdominal Hysterectomy for Benign Disease, run by Hospital de Concentracion Norte de Petroleos at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss measured by anesthesiology service during the procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654849, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008; AzTrials last refreshed its copy on 8 Nov 2026.