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OpenTrials
Completed

NCT Number: NCT01578759

Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

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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Key information

Conditions

Laparoscopic Hysterectomy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salpingectomy

Procedure

Removal of the fallopian tubes

Primary outcomes

  1. Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)

    Time frame: 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 outcomes

  1. Patient demographics

    Time frame: Prior to surgery

    The following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.

  2. Patient surgical outcomes

    Time frame: Postoperatively on day 1

    The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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