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NCT Number: NCT03045965

Hysterectomy and OPPortunistic SAlpingectomy

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.

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Key information

About this study

High grade serous ovarian cancer, the most fatal subtype, may originate in the fimbriae of the Fallopian tubes. This theory has led to the idea of opportunistic salpingectomy as a way of decreasing the risk of epithelial ovarian cancer (EOC). HOPPSA is a national register-based RCT, with randomization and follow-up in The Swedish National Quality Register of Gynecological Surgery (Gyn/Op).

HOPPSA aims to study if opportunistic salpingectomy is safe, and if it can reduce the risk of EOC.

PICO P (patients). Women <55 years, undergoing hysterectomy due to a benign reason I (intervention). Bilateral salpingectomy at the time of hysterectomy C (comparison). No salpingectomy O (outcomes). Primary short term: surgical complications reported according to Clavien-Dindo at 8 weeks post-operatively Intermediate term: change in menopausal symptoms from baseline to 1 year, assessed with Menopause Rating Scale Long term: ovarian cancer assessed through the National Cancer Register Recruitment of 4400 patients is estimated to take 4-6 years depending on the participation rate of the Swedish gynecological clinics. Data retrieval from GynOp on short and intermediate term outcomes, requiring smaller sample sizes, will be done at the end of the recruitment period. If these results, ready available when the study recruitment is closed, show that opportunistic salpingectomy does not increase surgical complications and menopausal symptoms, women can be advised to undergo salpingectomy to potentially minimize the future risk of EOC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salpingectomy

Procedure

The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.

Primary outcomes

  1. Surgical complication - short term primary outcome

    Time frame: Eight weeks post-operative

    Dichotomous outcome, retrieved from any of two sources in the GynOp register: specified question on complications and the Clavien-Dindo classification

  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 classified 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 outcomes

  1. Operative time

    Time frame: At day of surgery

    Continous outcome, registered in minutes

  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

    Continous outcome, registered in days

  3. Perioperative blood loss

    Time frame: At day of surgery

    Continous outcome, registered in ml

  4. Conversion to other surgical route

    Time frame: At day of surgery

    Dichotomous outcome

  5. Failure rate of salpingectomy at planned vaginal hysterectomy

    Time frame: At day of surgery

    Dichotomous outcome

  6. Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)

    Time frame: One and five years after surgery

    Dichotomous outcome based on MRS

  7. Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline

    Time frame: One year after surgery

    Continous outcome, measured in mg/L

  8. Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries

    Time frame: At one and up to ten years after surgery

    Dichotomous outcome, accompanied by a description of number and types of surgery performed

  9. Use of Hormone Replacement Therapy (HRT)

    Time frame: At one and up to ten years after surgery

    Dichotomous outcome

  10. Cardiovascular disease

    Time frame: 10-30 years after surgery

    Dichotomous outcome, accompanied by the specific ICD diagnoses

  11. Fractures (primarily radial, vertebral and hip fractures)

    Time frame: 10-30 years after surgery

    Dichotomous outcome, accompanied by the specific ICD diagnoses

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Umeå University
  • Vastra Gotaland Region

Registry information

Acronym: HOPPSA

Important dates

Study start
2017
Primary completion
2026
Study completion
2053
First posted
Feb 8, 2017
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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