Clinical trial NCT03322605: Residual Tubal Tissue on the Ovarian Surface Following Salpingectomy With Laparoscopy and Laparotomy
Official title: Investigation of the Presence of Residual Tubal Tissue on the Ovarian Surface Following Laparoscopic and Laparotomic Salpingectomy; Do They Really Exist?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salpingectomy
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo salpingo-oophorectomy +/- hysterectomy (laparoscopic or laparotomy) for benign indications, early cervical cancer or low-risk endometrial cancer will be included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of tubal tissue remnants on the ovarian surface
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Medeniyet University, Faculty of Medicine
name: Ozkan OZDAMAR, M.D.
role: PRINCIPAL_INVESTIGATOR
References: