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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Hakan Aytan, Adana Numune Training and Research Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745315
First Posted: December 10, 2012
Last Update Posted: January 30, 2013
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.
Information provided by (Responsible Party):
Hakan Aytan, Adana Numune Training and Research Hospital
  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
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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
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

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
First Submitted: December 6, 2012
First Posted: December 10, 2012
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