Opportunistic Salpingectomy at the Time of Benign Laparoscopic Hysterectomy

NCT ID: NCT03921138

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Benign Laparoscopic Hysterectomy Systematic Salpingectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Benign laparoscopic hysterectomy

Patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Histopathologic tube anomalies

Intervention Type OTHER

Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)

Interventions

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Histopathologic tube anomalies

Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gautier Chene, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon (Hôpital Femme Mère Enfant)

Other Identifiers

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SLH

Identifier Type: -

Identifier Source: org_study_id

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