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

Sponsor
Adana Numune Training and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01745315
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
3.9
Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Advanced bipolar devices
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

    Primary Outcome Measures

    1. Perioperative Outcomes [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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Adana Numune Training and Research Hospital Adana Turkey 01150

    Sponsors and Collaborators

    • Adana Numune Training and Research Hospital

    Investigators

    • Principal Investigator: Hakan Aytan, M.D., Adana Numune Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Dec 10, 2012
    Last Update Posted:
    Jan 30, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Hakan Aytan, Associate Professor,, Adana Numune Training and Research Hospital
    total laparoscopic hysterectomy
    LigaSure
    EnSeal
    Halo PKS Cutting forceps
    electrothermal bipolar vessel sealer
    advanced bipolar device

    Study Results

    No Results Posted as of Jan 30, 2013