Benign Uterine DiseaseNCT01217866
A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH
An observational study of Benign Uterine Disease, run by Womens Care.
Trial summary
Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Benign Uterine Disease
- What is being tested?
- Laparoscopic assisted vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Feb 2011
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)
Who may be able to join
- none, observational study
Who cannot join
- none, observational study
About this study
Official title: A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy
Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.
Read the detailed description
79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever >100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.
- Conditions
- Benign Uterine Disease
- Being tested
- Laparoscopic assisted vaginal hysterectomy
- Keywords
- laparoscopic, vaginal, hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic assisted vaginal hysterectomyProcedure or surgery
Surgical removal of uterus vaginally
| Study group | Role | What they receive |
|---|---|---|
| LAVH, techniques | Women aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally Receives: Procedure: Laparoscopic assisted vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
The total time the subject spent in surgery was compared between the two groups
Measured: Operating room time in minutes
Estimated blood loss
The total blood loss in cc per minutes operating was compared between the two groups
Measured: Blood loss during surgery in cc per minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Uterine DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Womens Care
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Principal investigator, Kathryn OKeeffe MD, Womens Care
- Investigators
- Katie O'Keeffe, MD, Principal investigator, Glens Falls Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217866
- Sponsor's protocol ID
- 1-44206615
- Status last verified
- Dec 2012
- First submitted
- 6 Oct 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT01217866
- Acronym / sponsor ID
- 1-44206615
- Conditions
- Benign Uterine Disease
- Keywords
- laparoscopic, vaginal, hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Womens CareUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Oct 2010 (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.
Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.
Detailed description
79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever >100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAVH, techniques | – | Procedure: Laparoscopic assisted vaginal hysterectomyWomen aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)
Key inclusion criteria (1 listed)
- none, observational study
Key exclusion criteria (1 listed)
- none, observational study
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 |
|---|---|---|
| Laparoscopic assisted vaginal hysterectomySurgical removal of uterus vaginally | Procedure or surgery | LAVH, techniques |
Primary outcome
Surgical time
Time frame: Operating room time in minutes
The total time the subject spent in surgery was compared between the two groups
Estimated blood loss
Time frame: Blood loss during surgery in cc per minute
The total blood loss in cc per minutes operating was compared between the two groups
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 20 Dec 2012.
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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.
Katie O'Keeffe, MD principal investigator
Glens Falls Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Uterine Disease, run by Womens Care.
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 20 Dec 2012. 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?
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?
Surgical time (time frame: Operating room time in minutes). 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?
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 20 Dec 2012.