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Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy (HYSTUB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281487
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Elisabeth-TweeSteden Ziekenhuis
Catharina Ziekenhuis Eindhoven
Radboud University
Jeroen Bosch Ziekenhuis
Information provided by (Responsible Party):
Jurgen M.J. Piek, Gynaecologisch Oncologisch Centrum Zuid

Brief Summary:
The purpose of this study is to determine whether a tubectomy during hysterectomy for benign gynaecological conditions does not result into a premature menopause.

Condition or disease Intervention/treatment Phase
Abdominal Hysterectomy (& Wertheim) Procedure: Hysterectomy plus Tubectomy Procedure: Hysterectomy Device: light microscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: Hysterectomy
standard hysterectomy
Procedure: Hysterectomy
standard hysterectomy

Experimental: Hysterectomy plus tubectomy
Hysterectomy plus tubectomy
Procedure: Hysterectomy plus Tubectomy
hysterectomy with tubectomy

Device: light microscopy
analysis of the incidence of dysplastic lesions (defined as: nuclear atypia, pilling of epithelial cells, multiple mitosis), if any, in the removed Fallopian tubes by light microscopy (Leica DM4000)




Primary Outcome Measures :
  1. Anti Mullerian Hormone [ Time Frame: at baseline and on average six months after the operation ]
    Difference, if any, in concentration of Anti Mullerian Hormone one day prior to hysterectomy and on average around six months after surgery between the study groups (hysterectomy alone versus hysterectomy and tubectomy).


Secondary Outcome Measures :
  1. Dysplasia [ Time Frame: on average six months after the operation ]
    Analysis of the incidence of dysplastic lesions (defined as: nuclear atypia, pilling of epithelial cells, multiple mitosis), if any, in the removed Fallopian tubes by light microscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • hysterectomy (abdominally or laparoscopically) for benign indications
  • premenopausal
  • age >36 < 55

Exclusion Criteria:

  • history of cancer
  • hereditary cancer in the family
  • previous intraluminal tubal occlusion
  • previous salpingitis
  • failure to perform a tubectomy during hysterectomy

Information from the National Library of Medicine

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): NCT02281487


Locations
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Netherlands
Jeroen Bosch ziekenhuis
Den Bosch, Brabant, Netherlands, 5223 GZ
Catharina Ziekenhuis
Eindhoven, Brabant, Netherlands, 5623EJ
Elisabeth ziekenhuis
Tilburg, Brabant, Netherlands, 5022 GC
TweeStedenziekenhuis
Tilburg, Brabant, Netherlands, 5042AD
Radboudumc
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Gynaecologisch Oncologisch Centrum Zuid
Elisabeth-TweeSteden Ziekenhuis
Catharina Ziekenhuis Eindhoven
Radboud University
Jeroen Bosch Ziekenhuis
Investigators
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Principal Investigator: Jurgen M Piek, MD. PhD. Gynaecologisch Oncologisch Centrum Zuid
Publications:
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Responsible Party: Jurgen M.J. Piek, MD. PhD., Gynaecologisch Oncologisch Centrum Zuid
ClinicalTrials.gov Identifier: NCT02281487    
Other Study ID Numbers: HYSTUB
NL39317.028.12 ( Other Identifier: CCMO )
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by Jurgen M.J. Piek, Gynaecologisch Oncologisch Centrum Zuid:
tubal carcinoma
ovarian carcinoma
tubectomy
hysterectomy
dysplastic changes
Anti Mullerian Hormone
Tubal Intraepithelial Carcinoma
Salpingectomy