NCT03258307

Brief Summary

Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in treatment of gynecological malignancy especially ovarian cancer and some advanced stage endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone secrete from adipose tissue. These regulate matabolic process. We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with gynecological malignancy performed omentectomy or not

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

August 15, 2017

Last Update Submit

August 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • with omentectomy group

    Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone

    1 year

  • No omentectomy group

    Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone

    1 year

Study Arms (3)

omentectomy

ACTIVE COMPARATOR

Preoperative

Other: Preoperative level

Omentectomy

OTHER

Postoperative

Other: Preoperative level

No omentectomy

OTHER

Preoperative post operative

Other: Preoperative level

Interventions

Blood sample

Also known as: Postoperative level
No omentectomyOmentectomyomentectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • gynecologic malignancy, staging surgery with or without omentectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Comba C, Ozdemir IA, Demirayak G, Erdogan SV, Demir O, Ozlem Yildiz G, Bulut H, Karakas S, Gulseren V, Afsar S, Gungorduk K. The effect of omentectomy on the blood levels of adipokines in obese patients with endometrial cancer. Obes Res Clin Pract. 2022 May-Jun;16(3):242-248. doi: 10.1016/j.orcp.2022.06.002. Epub 2022 Jun 11.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Gynecologic Oncology Bakirkoy Dr Sadi Konuk Training and Research Hospital

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 23, 2017

Study Start

February 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain

Locations