NCT02086344

Brief Summary

The aim of this RCT of study is to compare the standard TLH with adnexal preservation with TLH plus prophylactic bilateral salpingectomy (PBS) in terms of ovarian reserve and surgical outcomes

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

March 9, 2014

Last Update Submit

November 17, 2016

Conditions

Uterine FibroidsAdenomyosisPelvic PainPelvic Prolapse

Keywords

Total Laparoscopic HysterectomyTLHOvarian reserveProphylactic bilateral salpingectomyOvarian cancer preventionOvarian cancerFallopian Tubes

Outcome Measures

Primary Outcomes (1)

  • Ovarian reserve modification

    Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI

    Three months after laparoscopy

Secondary Outcomes (5)

  • Operative time

    The same day of surgery

  • variation of hemoglobin level

    two hours after the end of surgery

  • postoperative hospital stay

    The day of patient discharge

  • postoperative return to normal activity

    two months after surgery

  • complication rate

    The day of patient discharge

Study Arms (2)

TLH_plus_PBS

EXPERIMENTAL

TLH plus PBS

Procedure: PBS

TLH _adnexal preservation

ACTIVE COMPARATOR

Standard TLH without PBS

Procedure: TLH _adnexal preservation

Interventions

PBSPROCEDURE

TLH plus PBS

Also known as: Bilateral Salpingectomy
TLH_plus_PBS
TLH _adnexal preservationPROCEDURE

TLH without PBS

Also known as: Standard TLH without salpingectomy
TLH _adnexal preservation

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Indication to laparoscopic hysterectomy
  • Accomplished reproductive desire

You may not qualify if:

  • Patients with a family history of ovarian cancer and with a known mutation of the BRCA1/2 genes
  • Patients with a current or a past history of cancer
  • Patients who don't consent to the prophylactic salpingectomy
  • Previous adnexal surgery
  • PCOS
  • Estrogen-progestin therapy in the 2 months prior to the enrollment
  • Acute or chronic pelvic inflammatory disorders
  • Malignant gynecological neoplasms
  • Prior chemotherapy or radiotherapy
  • Autoimmune diseases, chronic, metabolic, endocrine and systemic disorders, including hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease
  • Hypogonadotropic hypogonadism
  • Taking medications that can cause menstrual irregularities
  • Other clinical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Obstetrics and Gynecology - University division - UMG

Catanzaro, CZ, 88100, Italy

RECRUITING

Related Publications (1)

  • Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, D'Alessandro P, Zullo F. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gynecol Oncol. 2013 Jun;129(3):448-51. doi: 10.1016/j.ygyno.2013.03.023. Epub 2013 Apr 2.

    PMID: 23558052BACKGROUND

MeSH Terms

Conditions

LeiomyomaAdenomyosisPelvic PainOvarian Neoplasms

Interventions

Salpingectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Fulvio Zullo

    Magna Graecia University of Catanzaro

    STUDY DIRECTOR

  • Roberta Venturella

    Magna Graecia University of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Zullo

CONTACT

39337947003zullo@unicz.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Obstetric Gynecology

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 13, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

IT(1)