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Hysterectomy and OPPortunistic SAlpingectomy (HOPPSA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045965
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : November 5, 2018
Sponsor:
Collaborators:
Vastra Gotaland Region
Umeå University
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason

  • has no increased risk of complications
  • has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures
  • implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Complication Procedure: Salpingectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Masking of the intervention is planned to include the one-year follow-up of menopausal symptoms.
Primary Purpose: Prevention
Official Title: Hysterectomy and Opportunistic Salpingectomy
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 2053


Arm Intervention/treatment
Experimental: Salpingectomy
Concomitant salpingectomy at the time of hysterectomy for a benign reason
Procedure: Salpingectomy
The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.

No Intervention: No salpingectomy
No salpingectomy at the time of hysterectomy for a benign reason



Primary Outcome Measures :
  1. Surgical complication - short term primary outcome [ Time Frame: Eight weeks post-operative ]
  2. Change in menopausal symptom score - intermediate term primary outcome [ Time Frame: One year after surgery ]
    Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)

  3. Epithelial ovarian cancer - long term primary outcome [ Time Frame: 10-30 years after surgery ]
    The outcome is dichotomous, the diagnosis is classifed according to ICD10. Each case with a positive outcome is further described with histopathological types and grade, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers


Secondary Outcome Measures :
  1. Operative time [ Time Frame: At day of surgery ]
  2. Length of hospital stay [ Time Frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a ]
  3. Perioperative blood loss [ Time Frame: At day of surgery ]
  4. Conversion to other surgical route [ Time Frame: At day of surgery ]
  5. Failure rate of salpingectomy at planned vaginal hysterectomy [ Time Frame: At day of surgery ]
  6. Prevalence of menopausal symptoms of at least moderate level according to Menopaus Rating Scale (MRS) [ Time Frame: One and five years after surgery ]
  7. Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline [ Time Frame: One year after surgery ]
  8. Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries [ Time Frame: At one and up to ten years after surgery ]
  9. Use of Hormone Replacement Therapy (HRT) [ Time Frame: At one and up to ten years after surgery ]
  10. Cardiovascular disease [ Time Frame: 10-30 years after surgery ]
  11. Fractures (primarily radial, vertebral and hip fractures) [ Time Frame: 10-30 years after surgery ]


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Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned hysterectomy for a benign reason
  • Age < 55 years at randomization
  • Willing to be randomized
  • Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy.

Exclusion Criteria:

  • Previous bilateral oophorectomy and/or salpingectomy
  • Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer))
  • Non-understanding of the oral or written study information

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): NCT03045965


Contacts
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Contact: Annika Strandell, PI +46 700904454 annika.strandell@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 413 45
Contact: Annika Strandell    700904454    annika.strandell@vgregion.se   
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Umeå University
Investigators
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Principal Investigator: Annika Strandell Sahlgrenska University Hospital, Sweden
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03045965    
Other Study ID Numbers: LUA-HTA-2016:86
VGFOUREG-650491 ( Other Grant/Funding Number: Vastra Gotaland Region )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Salpingectomy
Hysterectomy
Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders