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

January 29, 2013 updated by: Hakan Aytan, Adana Numune Training and Research Hospital

Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Adana, Turkey, 01150
        • Adana Numune Training and Research Hospital
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until 45 patients are operated (6 months anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adana Numune Training and Research Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • instruments in TLH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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