Prophylactic SalpingectomySaLCHENCT03171467
Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)
A study testing Salpingectomy in people with Prophylactic Salpingectomy and Opportunistic Salpingectomy, run by Medical University of Graz at 6 sites in Austria.
Trial summary
Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prophylactic Salpingectomy, Opportunistic Salpingectomy, Laparoscopic Cholecystectomy
- 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
- 100 participants
- Where
- 6 sitesAustria
- Study dates
- 1 Aug 2016to 1 Apr 2018
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled (elective) laparoscopic cholecystectomy for a benign indication
- Age >45 years
- Consent
Who cannot join
- Age <45 years
- Desire to preserve fertility
- Cholecystectomy for malignant disease
- Extensive previous abdominal surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Austria6 sites
Landeskrankenhaus Feldbach
Feldbach, 8330
Krankenhaus der Barmherzigen Brüder Graz
Graz, 8020
Krankenhaus der Elisabethinen Graz
Graz, 8020
Medical University of Graz
Graz, 8036
Landeskrankenhaus Hartberg
Hartberg, 8230
Krankenhaus der Barmherzigen Brüder St. Veit/Glan
Saint Veit/Glan, 9300
About this study
Official title: Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study
Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).
Read the detailed description
Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.
This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.
- Being tested
- Salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy | Experimental | Opportunistic salpingectomy at the time of laparoscopic cholecystectomy Receives: Procedure: Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy
Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy
Measured: At time of laparoscopic cholecystectomy surgery
Secondary outcomes (4)
Time
Time (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy
Measured: At the time of surgery
Port repositioning
Rate of port repositioning
Measured: At surgery
Complications
Number of complications due to salpingectomy
Measured: 30 days
Patient-recorded outcome
Bliem Questionnaire
Measured: Preop. and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Aug 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prophylactic SalpingectomyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Graz, Krankenhaus der Elisabethinen Graz, Landeskrankenhaus Feldbach, LKH Hartberg, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
- Responsible party
- Sponsor
- Investigators
- Karl F Tamussino, MD, Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171467
- Sponsor's protocol ID
- SaLCHE
- Acronym
- SaLCHE
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Long Roche KC, Abu-Rustum NR, Nourmoussavi M, Zivanovic O. Risk-reducing salpingectomy: Let us be opportunistic. Cancer. 2017 May 15;123(10):1714-1720. doi: 10.1002/cncr.30528. Epub 2017 Mar 23.
PubMed 28334425Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09.
PubMed 25560145Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
PubMed 25628372Kurman RJ, Shih IeM. The Dualistic Model of Ovarian Carcinogenesis: Revisited, Revised, and Expanded. Am J Pathol. 2016 Apr;186(4):733-47. doi: 10.1016/j.ajpath.2015.11.011.
PubMed 27012190
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study
- ClinicalTrials.gov ID
- NCT03171467
- Acronym / sponsor ID
- SaLCHE / SaLCHE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Graz, Krankenhaus der Elisabethinen Graz, Landeskrankenhaus Feldbach, LKH Hartberg, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).
Detailed description
Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.
This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy | Experimental | Procedure: SalpingectomyOpportunistic salpingectomy at the time of laparoscopic cholecystectomy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled (elective) laparoscopic cholecystectomy for a benign indication
- Age >45 years
- Consent
Key exclusion criteria (4 listed)
- Age <45 years
- Desire to preserve fertility
- Cholecystectomy for malignant disease
- Extensive previous abdominal surgery
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 |
|---|---|---|
| Salpingectomy | Procedure or surgery | Salpingectomy |
Primary outcome
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy
Time frame: At time of laparoscopic cholecystectomy surgery
Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy
4 secondary outcomes
Time
Time frame: At the time of surgery
Port repositioning
Time frame: At surgery
Complications
Time frame: 30 days
Patient-recorded outcome
Time frame: Preop. and 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 17 Apr 2018.
- Background: PubMed 28334425Long Roche KC, Abu-Rustum NR, Nourmoussavi M, Zivanovic O. Risk-reducing salpingectomy: Let us be opportunistic. Cancer. 2017 May 15;123(10):1714-1720. doi: 10.1002/cncr.30528. Epub 2017 Mar 23.
- Background: PubMed 25560145Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09.
- Background: PubMed 25628372Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.
- Background: PubMed 27012190Kurman RJ, Shih IeM. The Dualistic Model of Ovarian Carcinogenesis: Revisited, Revised, and Expanded. Am J Pathol. 2016 Apr;186(4):733-47. doi: 10.1016/j.ajpath.2015.11.011.
- Individual participant dataSharing planned: No
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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.
Karl F Tamussino, MD study chair
Medical University of Graz
6 sites 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 Prophylactic Salpingectomy and Opportunistic Salpingectomy, run by Medical University of Graz at 6 sites in Austria.
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 3 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: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria. 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?
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy (time frame: At time of laparoscopic cholecystectomy surgery). 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 NCT03171467, which also lists 4 linked publications.
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 17 Apr 2018.