Laparoscopic HysterectomyNCT01578759
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
A study testing Salpingectomy in people with Laparoscopic Hysterectomy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.
Who cannot join
- Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
- Personal history of gynecologic cancer
- Pregnancy
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Salpingectomy
- Keywords
- ovarian function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
Removal of the fallopian tubes
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy group | Experimental | Participants in this group will have their fallopian tubes removed. Receives: Procedure: Salpingectomy |
| No Salpingectomy Group | No intervention | Participants in this group will not have their fallopian tubes removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)
Measured: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.
Secondary outcomes (2)
Patient demographics
The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.
Measured: Prior to surgery
Patient surgical outcomes
The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.
Measured: Postoperatively on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Austin Findley, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578759
- Sponsor's protocol ID
- 12-0440
- Status last verified
- Oct 2014
- First submitted
- 11 Apr 2012
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.
PubMed 23993887
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
- ClinicalTrials.gov ID
- NCT01578759
- Acronym / sponsor ID
- 12-0440
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- ovarian function tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Apr 2012 (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 study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy group | Experimental | Procedure: SalpingectomyParticipants in this group will have their fallopian tubes removed. |
| No Salpingectomy Group | No intervention | –Participants in this group will not have their fallopian tubes removed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.
Key exclusion criteria (5 listed)
- Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
- Personal history of gynecologic cancer
- Pregnancy
- Non-English speaking
- Unable to provide informed consent
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 |
|---|---|---|
| SalpingectomyRemoval of the fallopian tubes | Procedure or surgery | Salpingectomy group |
Primary outcome
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)
Time frame: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.
2 secondary outcomes
Patient demographics
Time frame: Prior to surgery
Patient surgical outcomes
Time frame: Postoperatively on day 1
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 25 Apr 2017.
- Derived from this study: PubMed 23993887Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.
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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.
Austin Findley, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingectomy in people with Laparoscopic Hysterectomy, run by University of North Carolina, Chapel Hill 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 5 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 25 Apr 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?
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) (time frame: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578759, which also lists 1 linked publication.
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 25 Apr 2017.