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

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.

Study Overview

• Status: Completed
• Conditions: Benign Laparoscopic Hysterectomy; Systematic Salpingectomy
• Intervention / Treatment: Other: Histopathologic tube anomalies

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients who underwent benign laparoscopic hysterectomy with systematic salpingectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathologic tube anomalies	Prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma STIC or tumor protein 53 (p53) lesion)	day 1 of surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gautier Chene, PhD, Hospices Civils de Lyon (Hôpital Femme Mère Enfant)

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2014
• Primary Completion (Actual): January 31, 2016
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SLH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No