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The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.
A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salpingectomy | Experimental | Bilateral salpingectomy following cesarean delivery |
|
| Tubal Ligation | Active Comparator | Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Salpingectomy | Procedure | Surgical removal of entire fallopian tubes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery. | At least 24 but not greater than 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery. | Day of surgery |
| Estimated Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa E Torbenson, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Salpingectomy | Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes |
| FG001 | Tubal Ligation | Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Salpingectomy | Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes |
| BG001 | Tubal Ligation | Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) | Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery. | One patient in the Salpingectomy group is was missing post operation hemoglobin | Posted | Mean | Standard Deviation | g/dL | At least 24 but not greater than 48 hours after surgery |
|
Adverse event data was collected on participants six weeks from the date of cesarean delivery.
Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salpingectomy | Bilateral salpingectomy (surgical removal or entire fallopian tubes) following cesarean delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | CTCAE v4.0 | Systematic Assessment | Grade 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other, post-operative pain score above goal | Surgical and medical procedures | CTCAE v4.0 | Systematic Assessment | Grade 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Torbenson, M.D. | Mayo Clinic | 507-266-9873 | Torbenson.Vanessa@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 9, 2018 | Apr 11, 2019 | Prot_SAP_ICF_000.pdf |
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Two-arm randomized controlled trial
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| Bilateral Tubal Ligation |
| Procedure |
Surgical tying, cutting, or removal of a portion of the fallopian tubes |
|
Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.
| Day of surgery |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smoking Status | Count of Participants | Participants |
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| Repeat Cesarean | Count of Participants | Participants |
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| Gestational Age | Mean | Standard Deviation | weeks |
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| Gravity | Median | Inter-Quartile Range | Pregnancies |
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| Parity | Median | Inter-Quartile Range | viable pregnancies |
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| Education | Count of Participants | Participants |
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Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
|
|
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| Secondary | Operative Time | Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery. | Posted | Mean | Standard Deviation | mins | Day of surgery |
|
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| Secondary | Estimated Blood Loss | Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery. | Posted | Mean | Standard Deviation | mL | Day of surgery |
|
|
|
|
| 0 |
| 18 |
| 3 |
| 18 |
| 1 |
| 18 |
| EG001 | Tubal Ligation | Bilateral tubal ligation (surgical tying, cutting, or removal of a portion of the fallopian tubes)following cesarean delivery via Parkland or modified Pomeroy methods. | 0 | 20 | 0 | 20 | 2 | 20 |
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment | Grade 2 |
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| Uterine hemorrhage | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment | Grade 1 |
|
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| Breast pain | Reproductive system and breast disorders | CTCAE v4.0 | Systematic Assessment | Grade 2 |
|
| Upper respiratory infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment | Grade 2 |
|
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