Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy

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

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-07-31

Brief Summary

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Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.

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Detailed Description

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Conditions

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Benign Uterine Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LH alone

LH, laparoscopic hysterectomy

Group Type ACTIVE_COMPARATOR

LH alone

Intervention Type PROCEDURE

LH, laparoscopic hysterectomy

LH with opportunistic salpingectomy

LH, laparoscopic hysterectomy

Group Type EXPERIMENTAL

LH with opportunistic salpingectomy

Intervention Type PROCEDURE

LH, laparoscopic hysterectomy

Interventions

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LH alone

LH, laparoscopic hysterectomy

Intervention Type PROCEDURE

LH with opportunistic salpingectomy

LH, laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
* women aged between 19 and 52 years
* women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
* women who were appropriated medical status for laparoscopic surgery

Exclusion Criteria

* any ovarian cysts requiring ovarian surgery
* any suspicious findings of malignant diseases
* history of prior salpingectomy or salpingo-oophorectomy
* pregnant or menopausal status
* preoperative serum anti-Müllerian hormone (AMH) \< 0.30 ng/mL
* use of hormonal treatments in the three months before surgery
* any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
* an inability to understand and provide written informed consent.

Minimum Eligible Age

19 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No