MetrorrhagiaNCT01793584
Surgical Success After Laparoscopic vs Abdominal Hysterectomy
A study testing Laparoscopic hysterectomy and Abdominal hysterectomy in people with Metrorrhagia and Menorrhagia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial. 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
- Metrorrhagia, Menorrhagia, Leiomyoma
- What is being tested?
- Laparoscopic hysterectomy and Abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 31 Dec 2016
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
- Women >18 years of age
- Non-emergent surgery
- Non-pregnant
Who cannot join
- Candidate for vaginal hysterectomy
- Uterine size >14 weeks by clinical exam OR >300 mL by ultrasound measurement
- History of cancer of reproductive tract
- Requires concomitant pelvic organ prolapse (POP) surgery
- Requires surgery for urinary incontinence
- Has acute angle glaucoma
- Has severe cardiac/respiratory disease
- Desires supracervical hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.
Read the detailed description
The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.
- Conditions
- Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis
- Being tested
- Laparoscopic hysterectomy, Abdominal hysterectomy
- Keywords
- Comparative effectiveness, Surgical success
- Medical subject headings
- Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis, Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hysterectomyProcedure or surgery
LAVH, TLH
Abdominal hysterectomyProcedure or surgery
TAH
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic hysterectomy | Active comparator | Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy Receives: Procedure: Laparoscopic hysterectomy |
| Abdominal hysterectomy | Active comparator | Total Abdominal Hysterectomy Receives: Procedure: Abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
- Patient-centered outcomes composite
- Quality of life - measured using the Short Form 12 (SF-12v2),
- Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
- Body image - measured using the Body Image Scale (BIS)
- Return to normal activity -measured using the Activities Assessment Scale (AAS)
- Pain - measured using a 10 point likert scale
- Productivity - measured using a questionnaire about missed work
Measured: 1 year
Secondary outcomes (2)
Cost
Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated
Measured: 1 year
Complications
Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetrorrhagiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kinberly Kho, University of Texas Southwestern Medical Center
- Investigators
- Kimberly Kho, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793584
- Sponsor's protocol ID
- STU 032012-067
- Status last verified
- Oct 2017
- First submitted
- 13 Feb 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
- ClinicalTrials.gov ID
- NCT01793584
- Acronym / sponsor ID
- STU 032012-067
- Conditions
- Metrorrhagia, Menorrhagia, Leiomyoma, Adenomyosis, Pelvic Pain, Endometriosis
- Keywords
- Comparative effectiveness, Surgical success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 15 Feb 2013 (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.
The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through a randomized surgical trial.
Detailed description
The overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. The overall goal of the study is to determine which clinically relevant factors may impact the choice of LH compared to AH. The results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic hysterectomy | Active comparator | Procedure: Laparoscopic hysterectomyTotal laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy |
| Abdominal hysterectomy | Active comparator | Procedure: Abdominal hysterectomyTotal Abdominal Hysterectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women undergoing hysterectomy for benign indications within 8 weeks of enrollment
- Women >18 years of age
- Non-emergent surgery
- Non-pregnant
Key exclusion criteria (8 listed)
- Candidate for vaginal hysterectomy
- Uterine size >14 weeks by clinical exam OR >300 mL by ultrasound measurement
- History of cancer of reproductive tract
- Requires concomitant pelvic organ prolapse (POP) surgery
- Requires surgery for urinary incontinence
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 hysterectomyLAVH, TLH | Procedure or surgery | Laparoscopic hysterectomy |
| Abdominal hysterectomyTAH | Procedure or surgery | Abdominal hysterectomy |
Primary outcome
Quality of life
Time frame: 1 year
1) Patient-centered outcomes composite 1. Quality of life - measured using the Short Form 12 (SF-12v2), 2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ) 3. Body image - measured using the Body Image Scale (BIS) 4. Return to normal activity -measured using the Activities Assessment Scale (AAS) 5. Pain - measured using a 10 point likert scale 6. Productivity - measured using a questionnaire about missed work
2 secondary outcomes
Cost
Time frame: 1 year
Complications
Time frame: 1 year
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 26 Oct 2017.
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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.
Kimberly Kho, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic hysterectomy and Abdominal hysterectomy in people with Metrorrhagia and Menorrhagia, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 4 inclusion and 8 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Quality of life (time frame: 1 year). 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 26 Oct 2017.