Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Salpingectomy group

Participants in this group will have their fallopian tubes removed.

Group Type EXPERIMENTAL

Salpingectomy

Intervention Type PROCEDURE

Removal of the fallopian tubes

No Salpingectomy Group

Participants in this group will not have their fallopian tubes removed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Salpingectomy

Removal of the fallopian tubes

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No