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临床试验/NCT03322605
NCT03322605Unknown不适用

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

Istanbul Medeniyet University0 个研究点目标入组 60 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Percentage of tubal tissue remnants on the ovarian surface

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •Patients with other pelvic malignancies, previous bilateral salpingectomy or bilateral oophorectomy and excessive adhesions will be excluded.

结局指标

主要结局

Percentage of tubal tissue remnants on the ovarian surface

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özkan Özdamar

M.D.

Istanbul Medeniyet University

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