Hysterectomy and OPPortunistic SAlpingectomy (HOPPSA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Cancer; Complication
• Intervention / Treatment: Procedure: Salpingectomy

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 Type: Interventional
• Enrollment (Estimated): 4400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 54 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Continous outcome, registered in minutes	At day of surgery
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
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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Umeå University; Vastra Gotaland Region
• Investigators: Principal Investigator: Annika Strandell, Sahlgrenska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2053

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (Estimated): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ovarian cancer; Hysterectomy; Salpingectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Salpingectomy
• Other Study ID Numbers: LUA-HTA-2016:86; VGFOUREG-650491 (Other Grant/Funding Number: Vastra Gotaland Region)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No