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

C

CHA University

Status and phase

Completed
Phase 3

Conditions

Benign Uterine Disease

Treatments

Procedure: LH with opportunistic salpingectomy
Procedure: LH alone

Study type

Interventional

Funder types

Other

Identifiers

NCT01893086
KNC13-029

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

Female

Ages

19 to 52 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

LH alone
Active Comparator group
Description:
LH, laparoscopic hysterectomy
Treatment:
Procedure: LH alone
LH with opportunistic salpingectomy
Experimental group
Description:
LH, laparoscopic hysterectomy
Treatment:
Procedure: LH with opportunistic salpingectomy

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems