Hysterectomy and OPPortunistic SAlpingectomy

Ovarian Cancer Clinical Trial

— HOPPSA  

Official title:

Hysterectomy and Opportunistic Salpingectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03045965
• Other study ID #: LUA-HTA-2016:86
• Secondary ID: VGFOUREG-650491
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 2053

Study information

• Verified date: April 2023
• Source: Göteborg University
• Contact: Annika Strandell, PI
• Phone: +46 700904454
• Email: annika.strandell[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cardiovascular disease or incidence of fractures

• implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4400
• Est. completion date: December 2053
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Salpingectomy
The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Umeå University, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Operative time	Continous outcome, registered in minutes	At day of surgery
Secondary	Length of hospital stay	Continous outcome, registered in days	Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a
Secondary	Perioperative blood loss	Continous outcome, registered in ml	At day of surgery
Secondary	Conversion to other surgical route	Dichotomous outcome	At day of surgery
Secondary	Failure rate of salpingectomy at planned vaginal hysterectomy	Dichotomous outcome	At day of surgery
Secondary	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
Secondary	Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline	Continous outcome, measured in mg/L	One year after surgery
Secondary	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
Secondary	Use of Hormone Replacement Therapy (HRT)	Dichotomous outcome	At one and up to ten years after surgery
Secondary	Cardiovascular disease	Dichotomous outcome, accompanied by the specific ICD diagnoses	10-30 years after surgery
Secondary	Fractures (primarily radial, vertebral and hip fractures)	Dichotomous outcome, accompanied by the specific ICD diagnoses	10-30 years after surgery