Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy
Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 30, 2013
January 1, 2013
4 months
December 6, 2012
January 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perioperative Outcomes
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)
Study Arms (3)
LigaSure (advanced bipolar device)
ACTIVE COMPARATORLaparoscopic hysterectomy will be done with LigaSure in 15 patients.
Halo PKSforceps(advanced bipolar device)
ACTIVE COMPARATORLaparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.
EnSeal (advanced bipolar device)
ACTIVE COMPARATORLaparoscopic hysterectomy will be done with EnSeal in 15 patients.
Interventions
Eligibility Criteria
You may qualify if:
- any women with the indication of hysterectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adana Numune Training and Research Hospital
Adana, 01150, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Hakan Aytan, M.D.
Adana Numune Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor,
Study Record Dates
First Submitted
December 6, 2012
First Posted
December 10, 2012
Study Start
February 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
January 30, 2013
Record last verified: 2013-01