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Residual Tubal Tissue on the Ovarian Surface Following Salpingectomy With Laparoscopy and Laparotomy

NCT ID: NCT03322605

Last Updated: 2018-02-28

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-09-01

Brief Summary

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Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included. Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded. Laparoscopy and laparotomy groups will be compared in terms of fibril tissue remnants on the ovarian surface.

Detailed Description

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Histopathologic data have revealed that up to 70% of ovarian cancers may actually arise from the fallopian tube. Thus, opportunistic bilateral salpingectomy is now promoted for women at the time of hysterectomy for a benign disease. In turn, the potential surgical risks and ovarian cancer prevention of this emerging practice have generated multiple studies, some of which reported microscopic fimbriae were left behind adherent to the ovary. Although it is thought that there is no direct connection between the ovary and its adjacent fallopian tube, the investigators often find remnants of the fimbria adherent to the ovary at the time of surgery. If this tubo-ovarian interface is not separate, then practices such as salpingectomy and radical fimbriectomy may be incomplete, and the effectiveness of this technique as a prophylactic strategy may need reconsideration. In this study, the investigators aim to assess the presence of residual fimbrial/tubal tissue on ovarian surfaces following salpingectomy and to discuss the efficacy of this procedure on the reduction of epithelial ovarian cancer. Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included. Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded. Salpingectomy with or without hysterectomy, as indicated, will be performed initially. This will be followed by bilateral oophorectomy as a second step within the same procedure. The ovaries and tubes removed will be sent in separately labelled containers: right tube, left tube, right ovary and left ovary. Histological assessment will be performed by gynecological pathologists. The fallopian tubes will be sectioned serially and ovaries will also be serially sectioned and examined for presence of any remnant tubal tissue.

Conditions

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Salpingectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included.

Exclusion Criteria

* Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Özkan Özdamar

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ozkan OZDAMAR, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University, Faculty of Medicine

Central Contacts

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Ozkan OZDAMAR, M.D.

Role: CONTACT

Phone: +905324766744

Email: [email protected]

Other Identifiers

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2017/250

Identifier Type: -

Identifier Source: org_study_id