Uterine Fibroids3DRCTNCT02192606
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
A study testing Storz 3D Laparoscopy System and 2D Laparoscopy in people with Uterine Fibroids and Abnormal Uterine Bleeding, run by Brigham and Women's Hospital at 2 sites in 2 countries.
Trial summary
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain
- What is being tested?
- Storz 3D Laparoscopy System and 2D Laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Read the detailed description
This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.
- Conditions
- Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
- Being tested
- Storz 3D Laparoscopy System, 2D Laparoscopy
- Keywords
- Laparoscopy, 3D Visual System, Total Hysterectomy
- Medical subject headings
- Leiomyoma, Metrorrhagia, Pelvic Pain, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storz 3D Laparoscopy SystemDevice
The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
2D LaparoscopyDevice
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| 2D Laparoscopy | Active comparator | The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy Receives: Device: 2D Laparoscopy |
| 3D laparoscopy | Active comparator | The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Receives: Device: Storz 3D Laparoscopy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Cuff Closure Times
The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
Measured: Start of vaginal cuff closure to end of vaginal cuff closure
Secondary outcomes (1)
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Measured: Time of Procedure End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon I. Einarsson, Brigham and Women's Hospital
- Investigators
- Jon Einarsson, MD, PhD, MPH, Principal investigator, Brigham and Women's HospitalSarah L Cohen, MD, MPH, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192606
- Sponsor's protocol ID
- 3DRCT
- Acronym
- 3DRCT
- Status last verified
- Jan 2018
- First submitted
- 5 Nov 2013
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
PubMed 16985832Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
PubMed 23072406Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
Ajao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6.
PubMed 31172324
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
- ClinicalTrials.gov ID
- NCT02192606
- Acronym / sponsor ID
- 3DRCT / 3DRCT
- Conditions
- Uterine Fibroids, Abnormal Uterine Bleeding, Pelvic Pain, Adenomyosis
- Keywords
- Laparoscopy, 3D Visual System, Total Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Posted 6 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Detailed description
This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D Laparoscopy | Active comparator | Device: 2D LaparoscopyThe standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy |
| 3D laparoscopy | Active comparator | Device: Storz 3D Laparoscopy SystemThe Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Storz 3D Laparoscopy SystemThe Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system. | Device | 3D laparoscopy |
| 2D LaparoscopyThe standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy. | Device | 2D Laparoscopy |
Primary outcome
Vaginal Cuff Closure Times
Time frame: Start of vaginal cuff closure to end of vaginal cuff closure
The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
1 secondary outcome
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
Time frame: Time of Procedure End
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16985832Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4.
- Background: PubMed 23072406Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
- BackgroundEinarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
- Derived from this study: PubMed 31172324Ajao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6.
- 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.
Jon Einarsson, MD, PhD, MPH principal investigator
Brigham and Women's Hospital
Sarah L Cohen, MD, MPH study director
Brigham and Women's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storz 3D Laparoscopy System and 2D Laparoscopy in people with Uterine Fibroids and Abnormal Uterine Bleeding, run by Brigham and Women's Hospital at 2 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Denmark. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vaginal Cuff Closure Times (time frame: Start of vaginal cuff closure to end of vaginal cuff closure). 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 NCT02192606, which also lists 4 linked publications.
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 24 Jan 2018.