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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy
Official Title  ICMJE Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Perioperative Outcomes
Intervention  ICMJE Device: Advanced bipolar devices
Other Names:
  • LigaSure
  • Halo PKS cutting forceps
  • EnSeal
Study Arms  ICMJE
  • Active Comparator: LigaSure (advanced bipolar device)
    Laparoscopic hysterectomy will be done with LigaSure in 15 patients.
    Intervention: Device: Advanced bipolar devices
  • Active Comparator: Halo PKSforceps(advanced bipolar device)
    Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.
    Intervention: Device: Advanced bipolar devices
  • Active Comparator: EnSeal (advanced bipolar device)
    Laparoscopic hysterectomy will be done with EnSeal in 15 patients.
    Intervention: Device: Advanced bipolar devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745315
Other Study ID Numbers  ICMJE instruments in TLH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hakan Aytan, Adana Numune Training and Research Hospital
Study Sponsor  ICMJE Adana Numune Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hakan Aytan, M.D. Adana Numune Training and Research Hospital
PRS Account Adana Numune Training and Research Hospital
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP