Operative TimeNCT06398769
VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy
A study testing SecuFix UM and VCare UM in people with Operative Time and Length of Hospital Stay, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial summary
Hysterectomy, the most commonly performed gynecological operation, can be carried out through various methods using a wide array of instruments and energy techniques. Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when… Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Operative Time, Length of Hospital Stay, Perioperative Complications
- What is being tested?
- SecuFix UM and VCare UM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2024
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 35-65 years
- hysterectomy for benign gynecological indications
Who cannot join
- history of urogynecologic procedures
- suspected gynecological malignancy,
- endometriosis,
- pelvic inflammatory disease,
- pelvic organ prolapse,
- unavailibility of operative records
About this study
Official title: Comparison of VCare and SecuFix Uterine Manipulator in Total Laparoscopic Hysterectomy
Hysterectomy, the most commonly performed gynecological operation, can be carried out through various methods using a wide array of instruments and energy techniques. Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when compared to abdominal hysterectomy. Furthermore, recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation plays a crucial role in laparoscopic hysterectomy by facilitating bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also prevents pneumoperitoneum loss by closing off the vaginal space. Despite these apparent benefits, there is no existing report comparing different types of uterine manipulators. Therefore, the purpose of this study was to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy based on operative time, length of hospital stay, estimated blood loss, perioperative complications, and subjective performance.
Read the detailed description
Introduction Hysterectomy is the most commonly performed gynecological operation and can be carried out through various methods using a wide array of instruments and energy techniques. Although the methods have advantages and disadvantages over each other, minimally invasive procedures are associated with less morbidity and perioperative recovery. Recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation is crucial in laparoscopic hysterectomy as it facilitates bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also maintains pneumoperitoneum. Currently, many uterine manipulators are available, but the evidence for their efficacy and safety is still unclear. The purpose of utilizing a uterine manipulator is to enhance surgical outcomes and reduce intraoperative complications, particularly concerning the bladder and ureter. It is important to visualize the anterior and posterior fornices and ensure maintenance of the pneumoperitoneum. Therefore, uterine manipulators play a crucial role in laparoscopic hysterectomy. However, none of the manipulators currently available possess all the characteristics of an ideal manipulator. Therefore, the investigators aimed to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy with regard to operative time, length of hospital stay, estimated blood loss, and perioperative complications.
- Being tested
- SecuFix UM, VCare UM
- Keywords
- uterine manipulator, laparoscopy, Instruments, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecuFix UMDevice
All surgeries were performed using Secufix UM.
VCare UMDevice
All surgeries were performed using VCare UM.
| Study group | Role | What they receive |
|---|---|---|
| SecuFix UM | Experimental | SecuFix UM arm: patients undergoing total laparoscopic hysterectomy Receives: Device: SecuFix UM |
| VCare UM | Active comparator | VCare UM arm: patients undergoing total laparoscopic hysterectomy Receives: Device: VCare UM |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Operation time was defined as the duration from the skin incision to detachment of the uterus.
Measured: Operation time was defined as the duration in minutes from the skin incision to detachment of the uterus during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operative TimeStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Esra Keles, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398769
- Sponsor's protocol ID
- uterinemanipulator-1
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset used and/or analyzed in the study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VCare and SecuFix Uterine Manipulator in Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT06398769
- Acronym / sponsor ID
- uterinemanipulator-1
- Keywords
- uterine manipulator, laparoscopy, Instruments, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- May 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 3 May 2024 (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.
Hysterectomy, the most commonly performed gynecological operation, can be carried out through various methods using a wide array of instruments and energy techniques. Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when compared to abdominal hysterectomy. Furthermore, recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation plays a crucial role in laparoscopic hysterectomy by facilitating bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also prevents pneumoperitoneum loss by closing off the vaginal space. Despite these apparent benefits, there is no existing report comparing different types of uterine manipulators. Therefore, the purpose of this study was to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy based on operative time, length of hospital stay, estimated blood loss, perioperative complications, and subjective performance.
Detailed description
Introduction Hysterectomy is the most commonly performed gynecological operation and can be carried out through various methods using a wide array of instruments and energy techniques. Although the methods have advantages and disadvantages over each other, minimally invasive procedures are associated with less morbidity and perioperative recovery. Recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation is crucial in laparoscopic hysterectomy as it facilitates bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also maintains pneumoperitoneum. Currently, many uterine manipulators are available, but the evidence for their efficacy and safety is still unclear. The purpose of utilizing a uterine manipulator is to enhance surgical outcomes and reduce intraoperative complications, particularly concerning the bladder and ureter. It is important to visualize the anterior and posterior fornices and ensure maintenance of the pneumoperitoneum. Therefore, uterine manipulators play a crucial role in laparoscopic hysterectomy. However, none of the manipulators currently available possess all the characteristics of an ideal manipulator. Therefore, the investigators aimed to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy with regard to operative time, length of hospital stay, estimated blood loss, and perioperative complications.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| SecuFix UM | Experimental | Device: SecuFix UMSecuFix UM arm: patients undergoing total laparoscopic hysterectomy |
| VCare UM | Active comparator | Device: VCare UMVCare UM arm: patients undergoing total laparoscopic hysterectomy |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 35-65 years
- hysterectomy for benign gynecological indications
Key exclusion criteria (6 listed)
- history of urogynecologic procedures
- suspected gynecological malignancy,
- endometriosis,
- pelvic inflammatory disease,
- pelvic organ prolapse,
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 |
|---|---|---|
| SecuFix UMAll surgeries were performed using Secufix UM. | Device | SecuFix UM |
| VCare UMAll surgeries were performed using VCare UM. | Device | VCare UM |
Primary outcome
operative time
Time frame: Operation time was defined as the duration in minutes from the skin incision to detachment of the uterus during surgery.
Operation time was defined as the duration from the skin incision to detachment of the uterus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No. The dataset used and/or analyzed in the study are available from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing SecuFix UM and VCare UM in people with Operative Time and Length of Hospital Stay, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
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 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
operative time (time frame: Operation time was defined as the duration in minutes from the skin incision to detachment of the uterus during surgery.). 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 3 May 2024.