Perioperative PeriodNCT02822820
The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers
A study testing Ligasure-Covidien and RoBi forceps-Karl Storz in people with Perioperative Period, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perioperative Period
- What is being tested?
- Ligasure-Covidien and RoBi forceps-Karl Storz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2016to Mar 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of endometrial or cervix cancer
- Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy
- Clinically stage I and II endometrial cancer
Who cannot join
- Hematologic abnormality
- Coagulation disorder
- Present or past thromboembolic disease
- ECOG performance >2
- Advanced stage disease
- Fertility preserving surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical Faculty Hospital
Ankara, 06100
About this study
Official title: The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial
This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.
- Conditions
- Perioperative Period
- Being tested
- Ligasure-Covidien, RoBi forceps-Karl Storz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligasure-CovidienDevice
Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy
RoBi forceps-Karl StorzDevice
Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Advanced bipolar (Ligasure-Covidien) | Active comparator | Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy Receives: Device: Ligasure-Covidien |
| Conventional bipolar (RoBi forceps-Karl Storz) | Active comparator | Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy Receives: Device: RoBi forceps-Karl Storz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of operation
Measured: six months
Perioperative complications
Measured: six months
Secondary outcomes (2)
Pain measured by Visual Analog Scale
Measured: Postoperative pain scores at 8th and 24th hours
Total cost of hospitalization, operation and complications
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative PeriodStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih taskin, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822820
- Sponsor's protocol ID
- 03
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
Publications
Taskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11.
PubMed 29323616
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02822820
- Acronym / sponsor ID
- 03
- Conditions
- Perioperative Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Jul 2016 (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.
This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced bipolar (Ligasure-Covidien) | Active comparator | Device: Ligasure-CovidienDevices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy |
| Conventional bipolar (RoBi forceps-Karl Storz) | Active comparator | Device: RoBi forceps-Karl StorzDevices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pathologic diagnosis of endometrial or cervix cancer
- Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy
- Clinically stage I and II endometrial cancer
Key exclusion criteria (6 listed)
- Hematologic abnormality
- Coagulation disorder
- Present or past thromboembolic disease
- ECOG performance >2
- Advanced stage disease
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 |
|---|---|---|
| Ligasure-CovidienVessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy | Device | Advanced bipolar (Ligasure-Covidien) |
| RoBi forceps-Karl StorzVessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy | Device | Conventional bipolar (RoBi forceps-Karl Storz) |
Primary outcome
Duration of operation
Time frame: six months
Perioperative complications
Time frame: six months
2 secondary outcomes
Pain measured by Visual Analog Scale
Time frame: Postoperative pain scores at 8th and 24th hours
Total cost of hospitalization, operation and complications
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 29323616Taskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligasure-Covidien and RoBi forceps-Karl Storz in people with Perioperative Period, run by Ankara University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 25 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of operation (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822820, which also lists 1 linked publication.
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 25 Apr 2017.