Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VGFOUREG-650491 | Other Grant/Funding Number | Vastra Gotaland Region |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vastra Gotaland Region | OTHER_GOV |
| Umeå University | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salpingectomy | Experimental | Concomitant 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salpingectomy | Procedure | The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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 | 10-30 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Continous outcome, registered in minutes | At day of surgery |
| Length of hospital stay | Continous outcome, registered in days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Annika Strandell | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42157582 | Derived | 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 May 19. doi: 10.1111/aogs.70247. Online ahead of print. | |
| 36959664 | Derived | Idahl 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2024 | Sep 25, 2024 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Masking of the intervention is planned to include the one-year follow-up of menopausal symptoms.
| 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 | At day of surgery |
| Conversion to other surgical route | Dichotomous outcome | At day of surgery |
| Failure rate of salpingectomy at planned vaginal hysterectomy | Dichotomous outcome | At day of surgery |
| Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS) | Dichotomous outcome based on MRS | 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 | 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 | At one and up to ten years after surgery |
| Use of Hormone Replacement Therapy (HRT) | Dichotomous outcome | At one and up to ten years after surgery |
| Cardiovascular disease | Dichotomous outcome, accompanied by the specific ICD diagnoses | 10-30 years after surgery |
| Fractures (primarily radial, vertebral and hip fractures) | Dichotomous outcome, accompanied by the specific ICD diagnoses | 10-30 years after surgery |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |