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Active, Not Recruiting

NCT Number: NCT03860805

SALpingectomy for STERilization (SALSTER)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sterilization Tubal Laparoscopy Ovarian Reserve Salpingectomy

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic tubal ligation

Procedure

Laparoscopic tubal ligation

Laparoscopic bilateral salpingectomy

Procedure

Laparoscopic bilateral salpingectomy

Primary outcomes

  1. Complications

    Time frame: 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.

  2. Age at menopause

    Time frame: Twenty years

    Determined from questionnaires on bleeding pattern in GynOp. Continuous data.

Secondary outcomes

  1. Severe complications

    Time frame: Eight weeks post-operatively

    Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.

  2. Operative time

    Time frame: At day of surgery

    In minutes. Continous data.

  3. Perioperative blood loss

    Time frame: At day of surgery

    In millilitres. Continous data.

  4. Length of hospital stay

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

    In Days. Continous data.

  5. Complications according to Clavien-Dindo

    Time frame: One year after surgery

    Assessed according to Clavien-Dindo. Binary data.

  6. Complications

    Time frame: One year after surgery

    Assessed according to the existing questions on complications in GynOp. Binary data.

  7. Age at the start of the perimenopausal state

    Time frame: Up to 55 years of age

    Assessed through questionnaires in GynOp. Continous data.

  8. Length of the perimenopausal state

    Time frame: Up to 55 years of age

    Assessed in GynOp. Measured in days. Continous data.

  9. Change in menopausal symptom score

    Time frame: 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.

  10. Use of hormone replacement therapy at any time during follow-up

    Time frame: 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.

  11. Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.

    Time frame: 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.

  12. Pregnancy

    Time frame: At one year and up to 55 years of age

    Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.

  13. 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)

    Time frame: 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.

  14. Secondary expressions of estrogen deficiency

    Time frame: 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.

Other outcomes

  1. Absolute change in AMH

    Time frame: Measured at baseline and 1 year post-operatively

    Measured in mg/L. Continous data.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Umeå University

Registry information

Official study title

SALpingectomy for STERilization (SALSTER); a Randomized Trial

Acronym: SALSTER

Important dates

Study start
2019
Primary completion
2043
Study completion
2050
First posted
Mar 4, 2019
Registry last updated
Jan 17, 2025

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.

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