Abnormal Uterine Bleeding, UnspecifiedNCT01929148
Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy
A study testing Prophylactic bilateral salpingectomy and Laparoscopic myomectomy without PBS in people with Abnormal Uterine Bleeding, Unspecified, run by University Magna Graecia at 1 site in Italy.
Trial summary
We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Unspecified
- What is being tested?
- Prophylactic bilateral salpingectomy and Laparoscopic myomectomy without PBS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indication to laparoscopic myomectomy
- Accomplished reproductive desire
Who cannot join
- Age older than 50 years
- family history of ovarian cancer, BRCA positive
- basal FSH value of >20 IU/mL and/or E2 levels >60 pg/mL
- presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months >20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, CZ, 88100
Fulvio Zullo, MD, PhD, 39337947003, zullo@unicz.it
Roberta Venturella
About this study
Official title: Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?
We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative hospital stay, postoperative return to normal activity and complication rate) are related to PBS step in TLH.
Although the good statistical reliability of our retrospective data, we want to prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic parameters may possibly be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG Department) able to estimate the ovarian function both in term of reproductive ability that in term of distance from menopause.
Read the detailed description
We will enroll the first 77 patients who will agree to implement PBS to laparoscopic myomectomy (LM) (study group), starting from September 1, 2013. Other 77 patients who will ask us to undergo LM without the addiction of PBS will constitute the control group. For each patient, ovarian reserve modification before and after surgery will be recorded as the primary outcome. Specifically, one month before and three months after laparoscopy, on day 1 to 4 of menstrual cycles serum AMH, FSH and E2 will be evaluated and a transvaginal ultrasound examination (Voluson E8 Expert or Voluson-i - GE Healthcare Ultrasound) to assess AFC, OV, VI, FI and VFI, will be carried out by the same experienced ultrasonographist responsible for the ambulatory of ovarian reserve in each Unit.
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI. For each surgical procedure, moreover, operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.
- Conditions
- Abnormal Uterine Bleeding, Unspecified
- Being tested
- Prophylactic bilateral salpingectomy, Laparoscopic myomectomy without PBS
- Keywords
- risk-reducing salpingectomy, prophylactic bilateral salpingectomy, ovarian cancer prevention, ovarian reserve
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic bilateral salpingectomyProcedure or surgery
Also called PBS, bilateral salpingectomy
Salpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu
Laparoscopic myomectomy without PBSProcedure or surgery
Also called LM
Standard laparoscopic myomectomy without salpingectomy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic myomectomy plus PBS | Experimental | A Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire Receives: Procedure: Prophylactic bilateral salpingectomy |
| Laparoscopic myomectomy without PBS | Active comparator | A standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed Receives: Procedure: Laparoscopic myomectomy without PBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve modification
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), Ovarian volume (OV), Vascularization Index (VI), Flow index (FI) and Vascularization Flow Index (VFI)
Measured: three months after laparoscopy
Secondary outcomes (1)
Surgical outcomes
For each surgical procedure operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.
Measured: one day to one month after laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Abnormal Uterine Bleeding, UnspecifiedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulvio Zullo, University Magna Graecia
- Investigators
- Fulvio Zullo, Md, PhD, Study director, Magna Graecia University of CatanzaroRoberta Venturella, Principal investigator, Magna Graecia University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929148
- Sponsor's protocol ID
- PBS_myomectomy
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2013
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2.
PubMed 23558052
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?
- ClinicalTrials.gov ID
- NCT01929148
- Acronym / sponsor ID
- PBS_myomectomy
- Conditions
- Abnormal Uterine Bleeding, Unspecified
- Keywords
- risk-reducing salpingectomy, prophylactic bilateral salpingectomy, ovarian cancer prevention, ovarian reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Aug 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.
We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative hospital stay, postoperative return to normal activity and complication rate) are related to PBS step in TLH.
Although the good statistical reliability of our retrospective data, we want to prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D ultrasound parameters [AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI)]. Hormonal and ultrasonographic parameters may possibly be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG Department) able to estimate the ovarian function both in term of reproductive ability that in term of distance from menopause.
Detailed description
We will enroll the first 77 patients who will agree to implement PBS to laparoscopic myomectomy (LM) (study group), starting from September 1, 2013. Other 77 patients who will ask us to undergo LM without the addiction of PBS will constitute the control group. For each patient, ovarian reserve modification before and after surgery will be recorded as the primary outcome. Specifically, one month before and three months after laparoscopy, on day 1 to 4 of menstrual cycles serum AMH, FSH and E2 will be evaluated and a transvaginal ultrasound examination (Voluson E8 Expert or Voluson-i - GE Healthcare Ultrasound) to assess AFC, OV, VI, FI and VFI, will be carried out by the same experienced ultrasonographist responsible for the ambulatory of ovarian reserve in each Unit.
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI. For each surgical procedure, moreover, operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic myomectomy plus PBS | Experimental | Procedure: Prophylactic bilateral salpingectomyA Laparoscopic myomectomy plus Prophylactic bilateral salpingectomy will be performed in women which have accomplished their reproductive desire |
| Laparoscopic myomectomy without PBS | Active comparator | Procedure: Laparoscopic myomectomy without PBSA standard laparoscopic myomectomy without any prophylactic salpingectomy will be performed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Indication to laparoscopic myomectomy
- Accomplished reproductive desire
Key exclusion criteria (4 listed)
- Age older than 50 years
- family history of ovarian cancer, BRCA positive
- basal FSH value of >20 IU/mL and/or E2 levels >60 pg/mL
- presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months >20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.
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 |
|---|---|---|
| Prophylactic bilateral salpingectomyAlso: PBS, bilateral salpingectomySalpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu | Procedure or surgery | Laparoscopic myomectomy plus PBS |
| Laparoscopic myomectomy without PBSAlso: LMStandard laparoscopic myomectomy without salpingectomy | Procedure or surgery | Laparoscopic myomectomy without PBS |
Primary outcome
Ovarian reserve modification
Time frame: three months after laparoscopy
Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), Ovarian volume (OV), Vascularization Index (VI), Flow index (FI) and Vascularization Flow Index (VFI)
1 secondary outcome
Surgical outcomes
Time frame: one day to one month after laparoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Background: PubMed 23558052Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2.
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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.
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Fulvio Zullo, Md, PhD study director
Magna Graecia University of Catanzaro
Roberta Venturella principal investigator
Magna Graecia University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic bilateral salpingectomy and Laparoscopic myomectomy without PBS in people with Abnormal Uterine Bleeding, Unspecified, run by University Magna Graecia at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian reserve modification (time frame: three months after laparoscopy). 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 NCT01929148, 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 18 Nov 2016.