Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Not Applicable

Completed

• Conditions: Laparoscopic Hysterectomy
• Interventions: Procedure: Salpingectomy

• Registration Number: NCT01578759
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-15
• Study First Posted: 2012-04-17
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

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Exclusion Criteria

• Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
• Personal history of gynecologic cancer
• Pregnancy
• Non-English speaking
• Unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salpingectomy group	Salpingectomy	Participants in this group will have their fallopian tubes removed.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Patient demographics	Prior to surgery	The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.
Patient surgical outcomes	Postoperatively on day 1	The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.

Trial Locations

Locations (1)

Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States