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NCT02192606 · STUDY IN CONTEXT

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

secondary · POSTED

The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02192606
trial label
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0000
    source section id
    NCT02192606-om-0000
    source outcome index
    0
    endpoint
    Vaginal Cuff Closure Times
    endpoint definition
    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.
    time origin
    Start of vaginal cuff closure to end of vaginal cuff closure
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0001
    source section id
    NCT02192606-om-0001
    source outcome index
    1
    endpoint
    Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
    endpoint definition
    The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
    time origin
    Time of Procedure End
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0000
    arm key
    OG000
    arm label
    2D Laparoscopy
    regimen
    The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02192606-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0000
    arm key
    OG001
    arm label
    3D Laparoscopy
    regimen
    The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: 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.
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02192606-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0001
    arm key
    OG000
    arm label
    2D Laparoscopy
    regimen
    The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
    analyzed count
    29
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02192606-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    outcome key
    om-0001
    arm key
    OG001
    arm label
    3D Laparoscopy
    regimen
    The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: 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.
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02192606-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    harm key
    EG000
    source section id
    NCT02192606-ae
    event group key
    EG000
    event group label
    2D Laparoscopy
    serious affected
    0
    serious at risk
    29
    other affected
    3
    other at risk
    29
    frequency threshold
    0
    collection period
    Adverse event data was collected from the day of surgery to 8 weeks following the operation.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myoma
    nct id
    NCT02192606
    harm key
    EG001
    source section id
    NCT02192606-ae
    event group key
    EG001
    event group label
    3D Laparoscopy
    serious affected
    0
    serious at risk
    28
    other affected
    4
    other at risk
    28
    frequency threshold
    0
    collection period
    Adverse event data was collected from the day of surgery to 8 weeks following the operation.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice