Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Laparoscopic Hysterectomy Clinical Trial

Official title:

Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578759
• Other study ID #: 12-0440
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: April 21, 2017
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

Intervention

Procedure:
• Salpingectomy
Removal of the fallopian tubes

Locations

Country	Name	City	State
United States	Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

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