NCT03322605

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

October 24, 2017

Last Update Submit

February 27, 2018

Conditions

Salpingectomy

Outcome Measures

Primary Outcomes (1)

  • Percentage of tubal tissue remnants on the ovarian surface

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

    6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oophorectomy materials during hysterectomy or other gynecological procedures will be examined for fimbrial tissue remnants on their surface

Study Officials

  • Ozkan OZDAMAR, M.D.

    Istanbul Medeniyet University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozkan OZDAMAR, M.D.

CONTACT

+905324766744ozkan_ozdamar@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 26, 2017

Study Start

March 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02