Subtotal HysterectomyNCT02328274
A Modified Technique for Laparoscopic Subtotal Hysterectomy
An observational study of Subtotal Hysterectomy, run by Far Eastern Memorial Hospital.
Trial summary
Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subtotal Hysterectomy
- What is being tested?
- A Modified Technique for Laparoscopic Subtotal Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Nov 2014
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
Who may be able to join
- patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
- complete medical record
Who cannot join
- patients aged below 20 years old
- uterine malignancy
- incomplete medical record
About this study
Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. The standard surgical procedure in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus, dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel, monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative time and higher possibility of conversion to laparotomy due to technical difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a modified surgical technique of LASH which incorporated two methods of vessels ligation and laparoscopic in situ morcellation.
- Conditions
- Subtotal Hysterectomy
- Being tested
- A Modified Technique for Laparoscopic Subtotal Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Modified Technique for Laparoscopic Subtotal HysterectomyProcedure or surgery
incorporation of two methods of vessels ligation and laparoscopic in situ morcellation
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Measured: at time of surgery
Intraoperative blood loss
Measured: at time of surgery
Secondary outcomes (1)
Post-operative complications
such as ureteral injury, bowel perforation, conversion to laparotomy, recurrent vaginal bleeding
Measured: up to 7 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtotal HysterectomyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Chen Chuang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328274
- Sponsor's protocol ID
- 103138-E
- Status last verified
- Dec 2014
- First submitted
- 25 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Technique for Laparoscopic Subtotal Hysterectomy
- ClinicalTrials.gov ID
- NCT02328274
- Acronym / sponsor ID
- 103138-E
- Conditions
- Subtotal Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 31 Dec 2014 (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.
Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. The standard surgical procedure in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus, dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel, monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative time and higher possibility of conversion to laparotomy due to technical difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a modified surgical technique of LASH which incorporated two methods of vessels ligation and laparoscopic in situ morcellation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
Key inclusion criteria (2 listed)
- patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
- complete medical record
Key exclusion criteria (3 listed)
- patients aged below 20 years old
- uterine malignancy
- incomplete medical record
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 |
|---|---|---|
| A Modified Technique for Laparoscopic Subtotal Hysterectomyincorporation of two methods of vessels ligation and laparoscopic in situ morcellation | Procedure or surgery | – |
Primary outcome
Operation time
Time frame: at time of surgery
Intraoperative blood loss
Time frame: at time of surgery
1 secondary outcome
Post-operative complications
Time frame: up to 7 days post operation
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 31 Dec 2014.
Related trials for Subtotal Hysterectomy
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A Randomized Study Comparing Subtotal vs Total Hysterectomy Long Term Outcomes
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Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy
Hysterectomy
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?
An observational study of Subtotal Hysterectomy, run by Far Eastern Memorial 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 3 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 31 Dec 2014. 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?
Operation time (time frame: at time of surgery). 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 31 Dec 2014.