Ovarian CancerHOPPSANCT03045965
Hysterectomy and OPPortunistic SAlpingectomy
A study testing Salpingectomy in people with Ovarian Cancer and Complication, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 54 years, women only
- Conditions the study is for
- Ovarian Cancer, Complication
- What is being tested?
- Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2017to Dec 2053
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 54 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer, Complication
- Being tested
- Salpingectomy
- Keywords
- Salpingectomy, Hysterectomy, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy | Experimental | Concomitant salpingectomy at the time of hysterectomy for a benign reason Receives: Procedure: Salpingectomy |
| No salpingectomy | No intervention | No salpingectomy at the time of hysterectomy for a benign reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complication - short term primary outcome
Dichotomous outcome, retrieved from any of two sources in the GynOp register: specified question on complications and the Clavien-Dindo classification
Measured: Eight weeks post-operative
Change in menopausal symptom score - intermediate term primary outcome
Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)
Measured: One year after surgery
Epithelial ovarian cancer - long term primary outcome
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
Measured: 10-30 years after surgery
Secondary outcomes (11)
Operative time
Continous outcome, registered in minutes
Measured: At day of surgery
Length of hospital stay
Continous outcome, registered in days
Measured: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a
Perioperative blood loss
Continous outcome, registered in ml
Measured: At day of surgery
Conversion to other surgical route
Dichotomous outcome
Measured: At day of surgery
Failure rate of salpingectomy at planned vaginal hysterectomy
Dichotomous outcome
Measured: At day of surgery
Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)
Dichotomous outcome based on MRS
Measured: One and five years after surgery
Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline
Continous outcome, measured in mg/L
Measured: One year after surgery
Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries
Dichotomous outcome, accompanied by a description of number and types of surgery performed
Measured: At one and up to ten years after surgery
Use of Hormone Replacement Therapy (HRT)
Dichotomous outcome
Measured: At one and up to ten years after surgery
Cardiovascular disease
Dichotomous outcome, accompanied by the specific ICD diagnoses
Measured: 10-30 years after surgery
Fractures (primarily radial, vertebral and hip fractures)
Dichotomous outcome, accompanied by the specific ICD diagnoses
Measured: 10-30 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jun 2017
- Primary completionJun 2026 (estimated)
- Study completionDec 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Umeå University
- Responsible party
- Sponsor
- Investigators
- Annika Strandell, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045965
- Sponsor's protocol ID
- LUA-HTA-2016:86
- Other IDs
- VGFOUREG-650491
- Acronym
- HOPPSA
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2017
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darelius A, Idahl A, Sundfeldt K, Strandell A. Effect of opportunistic salpingectomy at hysterectomy on anti-Mullerian hormone: A substudy of a randomized trial. Acta Obstet Gynecol Scand. 2026 Aug;105(8):1480-1489. doi: 10.1111/aogs.70247. Epub 2026 May 19.
PubMed 42157582Idahl A, Liv P, Darelius A, Collins E, Sundfeldt K, Palsson M, Strandell A. HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial. Trials. 2023 Mar 24;24(1):222. doi: 10.1186/s13063-023-07244-w.
PubMed 36959664
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysterectomy and Opportunistic Salpingectomy
- ClinicalTrials.gov ID
- NCT03045965
- Acronym / sponsor ID
- HOPPSA / LUA-HTA-2016:86
- Conditions
- Ovarian Cancer, Complication
- Keywords
- Salpingectomy, Hysterectomy, Ovarian cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Umeå University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2053 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy | Experimental | Procedure: SalpingectomyConcomitant salpingectomy at the time of hysterectomy for a benign reason |
| No salpingectomy | No intervention | –No salpingectomy at the time of hysterectomy for a benign reason |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalpingectomyThe intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally. | Procedure or surgery | Salpingectomy |
Primary outcome
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
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)
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
11 secondary outcomes
Operative time
Time frame: At day of surgery
Length of hospital stay
Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a
Perioperative blood loss
Time frame: At day of surgery
Conversion to other surgical route
Time frame: At day of surgery
Failure rate of salpingectomy at planned vaginal hysterectomy
Time frame: At day of surgery
Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)
Time frame: One and five years after surgery
Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline
Time frame: One year after surgery
Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries
Time frame: At one and up to ten years after surgery
Use of Hormone Replacement Therapy (HRT)
Time frame: At one and up to ten years after surgery
Cardiovascular disease
Time frame: 10-30 years after surgery
Fractures (primarily radial, vertebral and hip fractures)
Time frame: 10-30 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42157582Darelius A, Idahl A, Sundfeldt K, Strandell A. Effect of opportunistic salpingectomy at hysterectomy on anti-Mullerian hormone: A substudy of a randomized trial. Acta Obstet Gynecol Scand. 2026 Aug;105(8):1480-1489. doi: 10.1111/aogs.70247. Epub 2026 May 19.
- Derived from this study: PubMed 36959664Idahl A, Liv P, Darelius A, Collins E, Sundfeldt K, Palsson M, Strandell A. HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial. Trials. 2023 Mar 24;24(1):222. doi: 10.1186/s13063-023-07244-w.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annika Strandell principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingectomy in people with Ovarian Cancer and Complication, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complication - short term primary outcome (time frame: Eight weeks post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.