Perioperative OutcomesNCT01745315
Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy
A study testing Advanced bipolar devices in people with Perioperative Outcomes, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perioperative Outcomes
- What is being tested?
- Advanced bipolar devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any women with the indication of hysterectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana Numune Training and Research Hospital
Adana, 01150
Hakan Aytan, Associate Professor, M.D., +905056833866, drhakanaytan@yahoo.com
Hakan Nazik, M.D.
About this study
Official title: 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.
- Conditions
- Perioperative Outcomes
- Being tested
- Advanced bipolar devices
- Keywords
- total laparoscopic hysterectomy, LigaSure, EnSeal, Halo PKS Cutting forceps, electrothermal bipolar vessel sealer, advanced bipolar device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced bipolar devicesDevice
Also called LigaSure, Halo PKS cutting forceps, EnSeal
| Study group | Role | What they receive |
|---|---|---|
| LigaSure (advanced bipolar device) | Active comparator | Laparoscopic hysterectomy will be done with LigaSure in 15 patients. Receives: Device: Advanced bipolar devices |
| Halo PKSforceps(advanced bipolar device) | Active comparator | Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients. Receives: Device: Advanced bipolar devices |
| EnSeal (advanced bipolar device) | Active comparator | Laparoscopic hysterectomy will be done with EnSeal in 15 patients. Receives: Device: Advanced bipolar devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 45 patients are operated (6 months anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adana Numune Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hakan Aytan, Adana Numune Training and Research Hospital
- Investigators
- Hakan Aytan, M.D., Principal investigator, Adana Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745315
- Sponsor's protocol ID
- instruments in TLH
- Status last verified
- Jan 2013
- First submitted
- 6 Dec 2012
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
- ClinicalTrials.gov ID
- NCT01745315
- Acronym / sponsor ID
- instruments in TLH
- Conditions
- Perioperative Outcomes
- Keywords
- total laparoscopic hysterectomy, LigaSure, EnSeal, Halo PKS Cutting forceps, electrothermal bipolar vessel sealer, advanced bipolar device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Adana Numune Training and Research HospitalOther government
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LigaSure (advanced bipolar device) | Active comparator | Device: Advanced bipolar devicesLaparoscopic hysterectomy will be done with LigaSure in 15 patients. |
| Halo PKSforceps(advanced bipolar device) | Active comparator | Device: Advanced bipolar devicesLaparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients. |
| EnSeal (advanced bipolar device) | Active comparator | Device: Advanced bipolar devicesLaparoscopic hysterectomy will be done with EnSeal in 15 patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any women with the indication of hysterectomy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced bipolar devicesAlso: LigaSure, Halo PKS cutting forceps, EnSeal | Device | EnSeal (advanced bipolar device), Halo PKSforceps(advanced bipolar device), LigaSure (advanced bipolar device) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
Related trials for Perioperative Outcomes
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty
Old Age; Debility, Digestive Cancer
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Aytan, M.D. principal investigator
Adana Numune Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced bipolar devices in people with Perioperative Outcomes, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Aytan, Associate Professor, M.D. (+905056833866, drhakanaytan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Outcomes (time frame: Until 45 patients are operated (6 months anticipated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.