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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

Tracking Information
First Submitted Date April 16, 2019
First Posted Date April 19, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date January 31, 2014
Actual Primary Completion Date January 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2019)
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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy
Official Title Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy : Assessment of Possible Complications and Histopathological Tumor Protein 53 (p53)-Signatures
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Condition
  • Benign Laparoscopic Hysterectomy
  • Systematic Salpingectomy
Intervention Other: Histopathologic tube anomalies
Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)
Study Groups/Cohorts Benign laparoscopic hysterectomy
Patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy
Intervention: Other: Histopathologic tube anomalies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2019)
100
Original Actual Enrollment Same as current
Actual Study Completion Date January 31, 2016
Actual Primary Completion Date January 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03921138
Other Study ID Numbers SLH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Gautier Chene, PhD Hospices Civils de Lyon (Hôpital Femme Mère Enfant)
PRS Account Hospices Civils de Lyon
Verification Date April 2019