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Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT01745315
Recruitment Status : Unknown
Verified January 2013 by Hakan Aytan, Adana Numune Training and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2012
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Hakan Aytan, Adana Numune Training and Research Hospital

Study Description
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Brief Summary:
There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the present study is to compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative complications, return of gastrointestinal activity and hospitalization time.

Condition or disease Intervention/treatment Phase
Perioperative Outcomes Device: Advanced bipolar devices Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
Study Start Date : February 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LigaSure (advanced bipolar device)
Laparoscopic hysterectomy will be done with LigaSure in 15 patients.
 Device: Advanced bipolar devices
Other Names:
  • LigaSure
  • Halo PKS cutting forceps
  • EnSeal
Active Comparator: Halo PKSforceps(advanced bipolar device)
Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.
 Device: Advanced bipolar devices
Other Names:
  • LigaSure
  • Halo PKS cutting forceps
  • EnSeal
Active Comparator: EnSeal (advanced bipolar device)
Laparoscopic hysterectomy will be done with EnSeal in 15 patients.
 Device: Advanced bipolar devices
Other Names:
  • LigaSure
  • Halo PKS cutting forceps
  • EnSeal


Outcome Measures
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Primary Outcome Measures :
  1. Perioperative Outcomes [ Time Frame: Until 45 patients are operated (6 months anticipated) ]
    Perioperative outcomes will be assessed with respect to complication rates, operation time, blood loss, change in hemoglobin and hemotocrit levels, time to return of gastrointestinal function and hospitalization time.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any women with the indication of hysterectomy

Exclusion Criteria:

  • malignancy
  • having 3 or more previous abdominal surgeries
  • uterus being larger than 12 weeks of gestation
  • patients who must undergo additional surgical procedures during the same operation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745315


Contacts
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Contact: Hakan Aytan, Associate Professor, M.D. +905056833866 drhakanaytan@yahoo.com

Locations
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Turkey
Adana Numune Training and Research Hospital
Adana, Turkey, 01150
Contact: Hakan Aytan, Associate Professor, M.D.    +905056833866    drhakanaytan@yahoo.com   
Sub-Investigator: Hakan Nazik, M.D.         
Sub-Investigator: Raziye Narin, M.D.         
Sub-Investigator: Murat Api, M.D., PhD.         
Principal Investigator: Hakan Aytan, M.D.         
Sponsors and Collaborators
Adana Numune Training and Research Hospital
Investigators
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Principal Investigator: Hakan Aytan, M.D. Adana Numune Training and Research Hospital
More Information
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Responsible Party: Hakan Aytan, Associate Professor,, Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01745315    
Other Study ID Numbers: instruments in TLH
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013
Keywords provided by Hakan Aytan, Adana Numune Training and Research Hospital:
total laparoscopic hysterectomy
LigaSure
EnSeal
 Halo PKS Cutting forceps
electrothermal bipolar vessel sealer
advanced bipolar device