Benign Laparoscopic HysterectomySLHNCT03921138
Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy
An observational study of Benign Laparoscopic Hysterectomy and Systematic Salpingectomy, run by Hospices Civils de Lyon.
Trial summary
In this prospective study, patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy were included. The aim of this study is to assess the prevalence of tubal histopathological abnormalities such as Serous Tubal Intraepithelial Carcinoma (STIC) and tumor protein 53 (p53) signatures) as well… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Laparoscopic Hysterectomy, Systematic Salpingectomy
- What is being tested?
- Histopathologic tube anomalies
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2014to 31 Jan 2016
- 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: Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Who may be able to join
- patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Who cannot join
- Hysterectomy in a context of gynecologic cancer
- Hysterectomy not carried out using laparoscopy
- Fimbriated end missing or damaged or impossible for pathologist to analyze
About this study
Official title: Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy : Assessment of Possible Complications and Histopathological Tumor Protein 53 (p53)-Signatures
In this prospective study, patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy were included. The aim of this study is to assess the prevalence of tubal histopathological abnormalities such as Serous Tubal Intraepithelial Carcinoma (STIC) and tumor protein 53 (p53) signatures) as well as the prevalence of perioperative and postoperative complications related to opportunistic laparoscopic salpingectomy in a low risk population. The hypothesis is that prophylactic salpingectomy during benign laparoscopic hysterectomy is both feasible and innocuous. Peri- and postoperative complications, duration of salpingectomy and post-salpingectomy blood loss, histopathological and immunohistochemical analysis with anti-p53 antibody were evaluated.
- Being tested
- Histopathologic tube anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathologic tube anomaliesOther
Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)
| Study group | Role | What they receive |
|---|---|---|
| Benign laparoscopic hysterectomy | Patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy Receives: Other: Histopathologic tube anomalies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathologic tube anomalies
Prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma STIC or tumor protein 53 (p53) lesion)
Measured: day 1 of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start31 Jan 2014
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Laparoscopic HysterectomyStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier Chene, PhD, Principal investigator, Hospices Civils de Lyon (Hôpital Femme Mère Enfant)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921138
- Sponsor's protocol ID
- SLH
- Acronym
- SLH
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy : Assessment of Possible Complications and Histopathological Tumor Protein 53 (p53)-Signatures
- ClinicalTrials.gov ID
- NCT03921138
- Acronym / sponsor ID
- SLH / SLH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 19 Apr 2019 (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 benign laparoscopic hysterectomy with systematic salpingectomy were included. The aim of this study is to assess the prevalence of tubal histopathological abnormalities such as Serous Tubal Intraepithelial Carcinoma (STIC) and tumor protein 53 (p53) signatures) as well as the prevalence of perioperative and postoperative complications related to opportunistic laparoscopic salpingectomy in a low risk population. The hypothesis is that prophylactic salpingectomy during benign laparoscopic hysterectomy is both feasible and innocuous. Peri- and postoperative complications, duration of salpingectomy and post-salpingectomy blood loss, histopathological and immunohistochemical analysis with anti-p53 antibody were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benign laparoscopic hysterectomy | – | Other: Histopathologic tube anomaliesPatients who underwent benign laparoscopic hysterectomy with systematic salpingectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Key inclusion criteria (1 listed)
- patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Key exclusion criteria (3 listed)
- Hysterectomy in a context of gynecologic cancer
- Hysterectomy not carried out using laparoscopy
- Fimbriated end missing or damaged or impossible for pathologist to analyze
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 |
|---|---|---|
| Histopathologic tube anomaliesAssessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion) | Other | Benign laparoscopic hysterectomy |
Primary outcome
Histopathologic tube anomalies
Time frame: day 1 of surgery
Prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma STIC or tumor protein 53 (p53) lesion)
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 19 Apr 2019.
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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.
Gautier Chene, PhD principal investigator
Hospices Civils de Lyon (Hôpital Femme Mère Enfant)
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Laparoscopic Hysterectomy and Systematic Salpingectomy, run by Hospices Civils de Lyon.
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: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Histopathologic tube anomalies (time frame: day 1 of 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 19 Apr 2019.