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The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salpingectomy group | Experimental | Participants in this group will have their fallopian tubes removed. |
|
| No Salpingectomy Group | No Intervention | Participants in this group will not have their fallopian tubes removed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salpingectomy | Procedure | Removal of the fallopian tubes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) | AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication. | Prior to surgery |
| Patient surgical outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Austin Findley, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23993887 | Derived | Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29. |
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| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.
| Postoperatively on day 1 |