LaparoscopyNCT05302622
Detecting the Most Efficient Residency Time for Laparoscopic Simulators
A study of Laparoscopy and Simulation Training, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators. This study planned as a prospective study. Read more about this study
- Who is it for?
- Ages 24 to 30 years
- Conditions the study is for
- Laparoscopy, Simulation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 15 Jun 2022
- 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 24 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Should be an ob/gyn resident
- Should except to participate study
Who cannot join
- Not to complete all simulations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Most Efficacious Period for the Use of Laparoscopic Simulators in Obstetrics and Gynecology Specialty Training
Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators.
This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.
- Conditions
- Laparoscopy, Simulation Training
- Being tested
- There is no intervention planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention planningOther
There is no intervention planning
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Have surgical experience both laparoscopy and laparotomy and senior resident Receives: Other: There is no intervention planning |
| Group 2 | Other | Have surgical skills only laparotomic gynecologic procedures and in the middle of his/her residency Receives: Other: There is no intervention planning |
| Group 3 | Other | Have no surgical experience on gynecologic procedures and newbie residents Receives: Other: There is no intervention planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laparoscopic surgical procedures time
Measured: 6 months
Secondary outcomes (2)
Movement number for laparoscopic procedures
Measured: 6 months
Complication during laparoscopic surgery simulations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Oct 2021
- Primary completion1 Jan 2022
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is three group based on the surgical skills and ob/gyn residency years.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahkam Göksel Kanmaz, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302622
- Sponsor's protocol ID
- 2021/10-48
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Most Efficacious Period for the Use of Laparoscopic Simulators in Obstetrics and Gynecology Specialty Training
- ClinicalTrials.gov ID
- NCT05302622
- Acronym / sponsor ID
- 2021/10-48
- Conditions
- Laparoscopy, Simulation Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 31 Mar 2022 (actual)
- 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.
Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators.
This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There is three group based on the surgical skills and ob/gyn residency years.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: There is no intervention planningHave surgical experience both laparoscopy and laparotomy and senior resident |
| Group 2 | Other | Other: There is no intervention planningHave surgical skills only laparotomic gynecologic procedures and in the middle of his/her residency |
| Group 3 | Other | Other: There is no intervention planningHave no surgical experience on gynecologic procedures and newbie residents |
Who may qualify
- Ages
- 24 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Should be an ob/gyn resident
- Should except to participate study
Key exclusion criteria (1 listed)
- Not to complete all simulations
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 |
|---|---|---|
| There is no intervention planningThere is no intervention planning | Other | Group 1, Group 2, Group 3 |
Primary outcome
Laparoscopic surgical procedures time
Time frame: 6 months
2 secondary outcomes
Movement number for laparoscopic procedures
Time frame: 6 months
Complication during laparoscopic surgery simulations
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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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 of Laparoscopy and Simulation Training, run by Tepecik 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 2 inclusion and 1 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 31 Mar 2022. 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?
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?
Laparoscopic surgical procedures time (time frame: 6 months). 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 31 Mar 2022.