CClinicalTrials.gg
CompletedNCT03258307Updated Aug 6, 2019

Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Pre-post Omentectomy

An interventional study of Preoperative level in Gynecologic Cancer, sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Istanbul Training and Research Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
Female
01

Study 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

Read the detailed description

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. Blood sample will study after 4000 rpm centrifugal for 10 minutes

02

Conditions studied

  • Gynecologic Cancer
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • gynecologic malignancy, staging surgery with or without omentectomy

Exclusion criteria

Exclusion Criteria:

  • not accept inclusion to trial
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    omentectomy

    Preoperative

    Other: Preoperative level

  • Other
    Omentectomy

    Postoperative

    Other: Preoperative level

  • Other
    No omentectomy

    Preoperative post operative

    Other: Preoperative level

Interventions

  • OtherPreoperative level

    Blood sample

    Also known as: Postoperative level

05

What researchers measure

Primary outcomes

  1. with omentectomy group

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

    Time frame: 1 year

  2. No omentectomy group

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

    Time frame: 1 year

06

Study locations

1 site
  • Bakirkoy Dr Sadi Konuk Training and Research Hospital
    İstanbul, 34000, Turkey
07

References and documents

Publications

  • 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. PubMed 35701296 ↗

Individual participant data

Plan to share: No — IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain

08

Registry details

Key details

Study ID
NCT03258307
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Isa Aykut Ozdemir (Head of Department of Gynecologic Oncology Bakirkoy Dr Sadi Konuk Training and Research Hospital, Istanbul Training and Research Hospital) — Principal investigator
First posted
Aug 23, 2017
Start date
Feb 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Aug 6, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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