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Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy (SLH)

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ClinicalTrials.gov Identifier: NCT03921138
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
Benign Laparoscopic Hysterectomy Systematic Salpingectomy Other: Histopathologic tube anomalies

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy : Assessment of Possible Complications and Histopathological Tumor Protein 53 (p53)-Signatures
Actual Study Start Date : January 31, 2014
Actual Primary Completion Date : January 31, 2016
Actual Study Completion Date : January 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Benign laparoscopic hysterectomy
Patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
 Other: Histopathologic tube anomalies
Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Criteria

Inclusion Criteria:

  • patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Exclusion Criteria:

  • Hysterectomy in a context of gynecologic cancer
  • Hysterectomy not carried out using laparoscopy
  • Fimbriated end missing or damaged or impossible for pathologist to analyze
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921138


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gautier Chene, PhD Hospices Civils de Lyon (Hôpital Femme Mère Enfant)
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03921138     History of Changes
Other Study ID Numbers: SLH
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No