SalpingectomyFPSNCT03187327
Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology
An observational study of Salpingectomy and Hysterectomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Salpingectomy, Hysterectomy
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jan 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy
Who may be able to join
- patients who underwent vaginal hysterectomy for benign pathology with salpingectomy or salpingo-oophorectomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology and Evaluation of Occult Tubal Lesions Prevalence: Preliminary Study
In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical (p53 expression) abnormalities were evaluated.
- Conditions
- Salpingectomy, Hysterectomy
- Keywords
- prophylactic salpingectomy, vaginal hysterectomy, p53 expression, ovarian cancers
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the surgical technique
prevalence of bilateral salpingectomy with or without ovariectomy
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startSep 2013
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier CHENE, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187327
- Sponsor's protocol ID
- 69HCL17_0352
- Acronym
- FPS
- Status last verified
- May 2017
- First submitted
- 13 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology and Evaluation of Occult Tubal Lesions Prevalence: Preliminary Study
- ClinicalTrials.gov ID
- NCT03187327
- Acronym / sponsor ID
- FPS / 69HCL17_0352
- Conditions
- Salpingectomy, Hysterectomy
- Keywords
- prophylactic salpingectomy, vaginal hysterectomy, p53 expression, ovarian cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Jun 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.
In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical (p53 expression) abnormalities were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy
Key inclusion criteria (1 listed)
- patients who underwent vaginal hysterectomy for benign pathology with salpingectomy or salpingo-oophorectomy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate of the surgical technique
Time frame: Day 0
prevalence of bilateral salpingectomy with or without ovariectomy
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 14 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Salpingectomy
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruiting
Prophylactic Salpingectomy With Delayed Oophorectomy
Ovarian Carcinoma
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
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.
Gautier CHENE principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salpingectomy and Hysterectomy, run by Hospices Civils de Lyon at 1 site in France.
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 0 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 14 Jun 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 France. 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?
Success rate of the surgical technique (time frame: Day 0). 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 14 Jun 2017.