Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

NCT ID: NCT01782807

Last Updated: 2013-02-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy.

In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established.

The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy

Detailed Description

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Conditions

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Ovarian Function Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hysterectomy

Hysterectomy without oophorectomy or salpingectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Hysterctomy with salpingectomy or fimbriectomy

Salpingectomy or Fimbriectomy

Group Type EXPERIMENTAL

Salpingectomy or Fimbriectomy

Intervention Type PROCEDURE

Interventions

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Salpingectomy or Fimbriectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause

Exclusion Criteria

* Menopause
* known or suspected malignancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kaplan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lion Poles

Deputy Director of Kaplan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaplan Medical Center

Rehovot, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Alon Ben- Arie, MD

Role: CONTACT

00-972-50-2460001

Yael Naaman, MD

Role: CONTACT

00-972-52-3499377

Facility Contacts

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Alon Ben- Arie, MD

Role: primary

Yael Naaman, MD

Role: backup

References

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Maseela T, Scheele R. [Hysterosalpingectomy. A contribution to the prevention of primary tubal neoplasms]. Fortschr Med. 1980 Jun 5;98(21):818-22. German.

Reference Type BACKGROUND
PMID: 7409710 (View on PubMed)

Zalel Y, Lurie S, Beyth Y, Goldberger S, Tepper R. Is it necessary to perform a prophylactic oophorectomy during hysterectomy? Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):67-70. doi: 10.1016/s0301-2115(97)02702-4.

Reference Type BACKGROUND
PMID: 9175692 (View on PubMed)

Morse AN, Hammer RA, Walter AJ, Baker S, Magtibay PM. Does hysterectomy without adnexectomy in patients with prior tubal interruption increase the risk of subsequent hydrosalpinx? Am J Obstet Gynecol. 2002 Dec;187(6):1483-5; discussion 1485-6. doi: 10.1067/mob.2002.130212.

Reference Type BACKGROUND
PMID: 12501050 (View on PubMed)

Farquhar CM, Sadler L, Harvey SA, Stewart AW. The association of hysterectomy and menopause: a prospective cohort study. BJOG. 2005 Jul;112(7):956-62. doi: 10.1111/j.1471-0528.2005.00696.x.

Reference Type BACKGROUND
PMID: 15957999 (View on PubMed)

Riedel HH, Lehmann-Willenbrock E, Semm K. Ovarian failure phenomena after hysterectomy. J Reprod Med. 1986 Jul;31(7):597-600.

Reference Type BACKGROUND
PMID: 3746790 (View on PubMed)

Bulent Tiras M, Noyan V, Ozdemir H, Guner H, Yildiz A, Yildirim M. The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):219-21. doi: 10.1016/s0301-2115(01)00410-9.

Reference Type BACKGROUND
PMID: 11788175 (View on PubMed)

Other Identifiers

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kmc0029-11

Identifier Type: -

Identifier Source: org_study_id

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