Laparoscopy, Ovarian Reserve, Salpingectomy, Sterilization Tubal
Conditions
Keywords
Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve
Brief summary
The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.
Detailed description
SALSTER Study In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation. The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited. In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited. The study is expected to start in the beginning of 2019 and the first results are expected in 2021.
Interventions
PROCEDURELaparoscopic tubal ligation
Laparoscopic tubal ligation
PROCEDURELaparoscopic bilateral salpingectomy
Laparoscopic bilateral salpingectomy
Sponsors
Umeå University
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Planned laparoscopic sterilization * Willing to be randomized
Exclusion criteria
* Women older than 49 * Not understanding the oral or written study information * Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Age at menopause | Twenty years | Determined from questionnaires on bleeding pattern in GynOp. Continuous data. |
| Complications | Eight weeks post-operatively | Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | At day of surgery | In minutes. Continous data. |
| Perioperative blood loss | At day of surgery | In millilitres. Continous data. |
| Length of hospital stay | Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks | In Days. Continous data. |
| Complications according to Clavien-Dindo | One year after surgery | Assessed according to Clavien-Dindo. Binary data. |
| Complications | One year after surgery | Assessed according to the existing questions on complications in GynOp. Binary data. |
| Age at the start of the perimenopausal state | Up to 55 years of age | Assessed through questionnaires in GynOp. Continous data. |
| Change in menopausal symptom score | Up to 55 years of age | Assessed with Menopause Rating Scale (MRS) in GynOp. MRS is a validated scale consisting of 11 questions, each yields a score of 1-4. Total score is reported, ranging from 4 to 44, where 4 indicates no menopausal symptoms and 44 maximum symptoms. Ordered categorical data. |
| Use of hormone replacement therapy at any time during follow-up | Up to 55 years of age | Either an answer yes to question in GynOp or prescription in The Drug Prescription Register will give information on the outcome (yes/no). Binary data. |
| Subsequent surgery on uterus, salpinges and/or ovaries. Binary data. | At one year and up to 55 years of age | Assessed through GynOp and through The Patient register. Both registers yield the same data (subsequent surgery yes/no). Binary data. |
| Pregnancy | At one year and up to 55 years of age | Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data. |
| Epithelial ovarian cancer including histopathological types and grade, primary tubal and peritoneal cancer, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO) | 40 years | Assessed through The Swedish Cancer Register, The Swedish Quality Register for Gynaecological Cancer, The Swedish Cause of Death Register and The Swedish Population Register. Time-to event data. |
| Secondary expressions of estrogen deficiency | 40 years | Measures of fractures related to osteoporosis and cardio-vascular events will be assessed through the Patient register. Binary and time-to-event data. |
| Length of the perimenopausal state | Up to 55 years of age | Assessed in GynOp. Measured in days. Continous data. |
| Severe complications | Eight weeks post-operatively | Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in AMH | Measured at baseline and 1 year post-operatively | Measured in mg/L. Continous data. |
Countries
Sweden
Outcome results
None listed