Hysterectomy
Conditions
Keywords
Sterilization, Hysteroscopic Device Placement, Tubal Ligation
Brief summary
The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had undergone sterilization through tubal ligation.
Interventions
DEVICEHysteroscopic device placement including Essure (ESS305, BAY1454032)
Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen
PROCEDURETubal ligation
Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 49 years at index date * Gender: Female * Diagnosis: Women who underwent hysteroscopic device sterilization procedure * Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy
Exclusion criteria
* Patients undergoing in-vitro fertilization (IVF) procedures * Embryo transfer, intrauterine * Follicle puncture for oocyte retrieval, any method
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients having hysterectomy procedure post-sterilization through hysteroscopic device placement | Retrospective analysis of 10 year period | The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH) |
| Percentage of patients having hysterectomy procedure post-sterilization through through tubal ligation | Retrospective analysis of 10 year period | The study will also describe sub-outcomes related to post-sterilization hysterectomy procedure including: i. Average time (in days) from index date (sterilization) to hysterectomy ii. Percentage of patients having hysterectomy (abdominal) iii. Percentage of patients having hysterectomy (vaginal) iv. Percentage of patients having hysterectomy (laproscopically assisted vaginal hysterectomy - LAVH) v. Percentage of patients having hysterectomy (abdominal, vaginal and LAVH) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients having unintended pregnancy post-sterilization | Retrospective analysis of 10 year period | Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization |
| Percentage of patients having unintended ectopic pregnancy post-sterilization | Retrospective analysis of 10 year period | Exclusion of any IVF pregnancy, and any pregnancy preceding sterilization |
| Percentage of patients that have salpingectomy (unilateral, bilateral) subsequent to sterilization | Retrospective analysis of 10 year period | — |
| Average time in days from sterilization to salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time) | Retrospective analysis of 10 year period | — |
| Average time in days from sterilization to removal of device inserts other than hysterectomy or salpingectomy and Kaplan-Meier-Estimator curve (number of occurrence over time) | Retrospective analysis of 10 year period | — |
| Percentage of patients with repeat sterilization surgery | Retrospective analysis of 10 year period | — |
| Average time in days from first sterilization to repeat sterilization surgery and Kaplan-Meier-Estimator curve (number of occurrence over time) | Retrospective analysis of 10 year period | — |
| Percentage of patients who undergo a Modified Hysterosalpingogram (HSG) test | Retrospective analysis of 10 year period | — |
| Percentage of patients who did not have a Modified HSG and unintentionally got pregnant | Retrospective analysis of 10 year period | — |
| Percentage of patients having readmission within 30 days of sterilization | Retrospective analysis of 10 year period | — |
| Percentage of patients having removal of device inserts other than hysterectomy or salpingectomy | Retrospective analysis of 10 year period | — |
| Percentage of patients who had Modified HSG and got pregnant | Retrospective analysis of 10 year period | — |
Countries
United States
Outcome results
None listed