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

This study is not yet open for participant recruitment.
Verified January 2013 by Adana Numune Training and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Hakan Aytan, Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01745315
First received: December 6, 2012
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Perioperative Outcomes
 Device: Advanced bipolar devices

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Adana Numune Training and Research Hospital:

Primary Outcome Measures:
  • Perioperative Outcomes [ Time Frame: Until 45 patients are operated (6 months anticipated) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 45
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745315

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

Locations
Turkey
Adana Numune Training and Research Hospital Not yet recruiting
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
Principal Investigator: Hakan Aytan, M.D. Adana Numune Training and Research Hospital
  More Information

No publications provided

Responsible Party: Hakan Aytan, Associate Professor,, Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01745315     History of Changes
Other Study ID Numbers: instruments in TLH
Study First Received: December 6, 2012
Last Updated: January 29, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Adana Numune Training and Research Hospital:
total laparoscopic hysterectomy
LigaSure
EnSeal
 Halo PKS Cutting forceps
electrothermal bipolar vessel sealer
advanced bipolar device

ClinicalTrials.gov processed this record on May 16, 2013