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Clinical Trials/NCT03322605
NCT03322605UnknownNot Applicable

Investigation of the Presence of Residual Tubal Tissue on the Ovarian Surface Following Laparoscopic and Laparotomic Salpingectomy; Do They Really Exist?

Istanbul Medeniyet University0 sites60 target enrollmentStarted: March 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Primary Endpoint
Percentage of tubal tissue remnants on the ovarian surface

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Percentage of tubal tissue remnants on the ovarian surface

Time Frame: 6 months

Percentage of tubal tissue remnants on the oophorectomy materials extracted either by laparotomy or laparoscopy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul Medeniyet University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Özkan Özdamar

M.D.

Istanbul Medeniyet University

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