Hysterectomy and OPPortunistic SAlpingectomy

NCT03045965 | Active Not Recruiting

• 2 other identifiers: LUA-HTA-2016:86VGFOUREG-650491
• Study Type: interventional
• Target: 4,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Complication

Keywords

Salpingectomy; Hysterectomy; Ovarian cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Operative time

  At day of surgery

• Length of hospital stay

  Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a

• Perioperative blood loss

  At day of surgery

• Conversion to other surgical route

  At day of surgery

• Failure rate of salpingectomy at planned vaginal hysterectomy

  At day of surgery

Study Arms (2)

Salpingectomy

EXPERIMENTAL

Concomitant salpingectomy at the time of hysterectomy for a benign reason

Procedure: Salpingectomy

No salpingectomy

NO INTERVENTION

No salpingectomy at the time of hysterectomy for a benign reason

Interventions

Salpingectomy PROCEDURE

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

Salpingectomy

Eligibility Criteria

• Age: 20 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator
• Umeå University: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36959664 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Salpingectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Annika Strandell

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking of the intervention is planned to include the one-year follow-up of menopausal symptoms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: February 8, 2017
• Study Start: June 1, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2053
• Last Updated: February 17, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)