Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
NCT Number: NCT03045965
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.
This study is active but is not currently recruiting participants.
Notify Me20 year–54 year
Female
Interventional
Not applicable
Gothenburg, 413 45, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.
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
Time frame: One year after surgery
Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)
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
Time frame: At day of surgery
Continous outcome, registered in minutes
Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a
Continous outcome, registered in days
Time frame: At day of surgery
Continous outcome, registered in ml
Time frame: At day of surgery
Dichotomous outcome
Time frame: At day of surgery
Dichotomous outcome
Time frame: One and five years after surgery
Dichotomous outcome based on MRS
Time frame: One year after surgery
Continous outcome, measured in mg/L
Time frame: At one and up to ten years after surgery
Dichotomous outcome, accompanied by a description of number and types of surgery performed
Time frame: At one and up to ten years after surgery
Dichotomous outcome
Time frame: 10-30 years after surgery
Dichotomous outcome, accompanied by the specific ICD diagnoses
Time frame: 10-30 years after surgery
Dichotomous outcome, accompanied by the specific ICD diagnoses
Göteborg University
Other
Acronym: HOPPSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05891171
Adenocarcinoma, Adnexal Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT05467670
Adnexal Diseases, Endocrine Gland Neoplasms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05787587
Adnexal Diseases, Advanced or Metastatic Solid Tumors
Phoenix, Arizona, United States
View Trial DetailsNCT04830709
Adnexal Diseases, Endocrine Gland Neoplasms
Böblingen, Germany
View Trial Details