Gynecologic DiseasesPhase 3NCT00734812
Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy
A Phase 3 study testing Laparoscopic supracervical hysterectomy and Total laparoscopic hysterectomy in people with Gynecologic Diseases, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Diseases
- What is being tested?
- Laparoscopic supracervical hysterectomy and Total laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2012
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidates for laparoscopic hysterectomy for benign indications
Who cannot join
- Malignancy of the uterus, cervix or adnexa
- pre-malignant changes of the uterus, cervix or adnexa
- history of severe cervical dysplasia (CIN II or above)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: LSH vs. TLH, A Randomized Single Blind Trial
The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.
Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).
Read more
Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.
6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.
- Conditions
- Gynecologic Diseases
- Being tested
- Laparoscopic supracervical hysterectomy, Total laparoscopic hysterectomy
- Keywords
- Hysterectomy, Laparoscopic
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic supracervical hysterectomyProcedure or surgery
Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
Total laparoscopic hysterectomyProcedure or surgery
Patients will be randomized to either removal or retention of cervix
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Laparoscopic supracervical hysterectomy (LSH) Receives: Procedure: Laparoscopic supracervical hysterectomy |
| 2 | Active comparator | Total Laparoscopic Hysterectomy (TLH) Receives: Procedure: Total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to normal activities
Measured: 3-6 weeks after surgery
Secondary outcomes (1)
Sexual function
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study was withdrawn prior to any enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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 I. Einarsson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734812
- Sponsor's protocol ID
- 2007-P-002591/1
- Status last verified
- Jan 2013
- First submitted
- 12 Aug 2008
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSH vs. TLH, A Randomized Single Blind Trial
- ClinicalTrials.gov ID
- NCT00734812
- Acronym / sponsor ID
- 2007-P-002591/1
- Conditions
- Gynecologic Diseases
- Keywords
- Hysterectomy, Laparoscopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to any enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Aug 2008 (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 this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.
Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).
Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.
6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Laparoscopic supracervical hysterectomyLaparoscopic supracervical hysterectomy (LSH) |
| 2 | Active comparator | Procedure: Total laparoscopic hysterectomyTotal Laparoscopic Hysterectomy (TLH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for laparoscopic hysterectomy for benign indications
Key exclusion criteria (3 listed)
- Malignancy of the uterus, cervix or adnexa
- pre-malignant changes of the uterus, cervix or adnexa
- history of severe cervical dysplasia (CIN II or above)
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 supracervical hysterectomyPatients will be randomized to LSH (retaining the cervix) and TLH (cervix removal) | Procedure or surgery | 1 |
| Total laparoscopic hysterectomyPatients will be randomized to either removal or retention of cervix | Procedure or surgery | 2 |
Primary outcome
Return to normal activities
Time frame: 3-6 weeks after surgery
1 secondary outcome
Sexual function
Time frame: 6 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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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 I. Einarsson, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic supracervical hysterectomy and Total laparoscopic hysterectomy in people with Gynecologic Diseases, run by Brigham and Women's Hospital 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 1 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: withdrawn, as of the sponsor's last update on 24 Jan 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Return to normal activities (time frame: 3-6 weeks after surgery). 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 24 Jan 2013.