NCT04366375

Brief Summary

Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

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

January 13, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 25, 2020

Last Update Submit

April 28, 2020

Conditions

Laparoscopic HysterectomyAbdominal Hysterectomy

Keywords

Pentraxin-3tissue traumahysterectomyneutrophil to lymphocyte ratio

Outcome Measures

Primary Outcomes (1)

  • Pentraxin-3 level

    Pentraxin-3 ng/mL

    Before 24 hours preoperatively and upto 24 hours postoperatively

Secondary Outcomes (1)

  • (NLR)

    Up to 24 hours postoperative

Study Arms (2)

TLH+BSO

Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20

Diagnostic Test: PTX-3

TAH + BSO

Total Abdominal Hysterectomy + BSO N=20

Diagnostic Test: PTX-3

Interventions

PTX-3DIAGNOSTIC_TEST

Pentraxin-3 ng/mL PTX-3 levels were measured using human PTX3 ELISA Kit 96 Tests/Box (Cat. No: CK-E90303) (Hangzhou Eastbiopharm Co.,Ltd., PRC) read by a ELISA device matching with the kit. For the purpose of measurement, microplate washer RT 2600 device and Rayto microplate reader RT 2100C device were used.

TAH + BSOTLH+BSO

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTLH+BSO and TAH+BSO applied patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 40 patients, composed of 20 TLH+BSO patients and 20 TAH+BSO patients were included into the study.

You may qualify if:

  • ·TLH+BSO patients and TAH+BSO patients

You may not qualify if:

  • History of a chronic disease (coronary artery disease, diabetes mellitus, hypertension, coronary liver failures, chronic kidney disease, chronic respiratory diseases, connective tissue disorders) which may affect levels of PTX-3 and other inflammatory markers.
  • Prior surgery due to malignancy.
  • History of an intra-abdominal surgery, except for cesarean section.
  • History of any disease which may lead to intra-abdominal adhesions (endometriosis, past pelvic infection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum blood samples for each participant

Study Officials

  • Burak SEZGİN, Dr

    Mugla Sıtkı Kocman University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

January 13, 2015

Primary Completion

December 7, 2015

Study Completion

December 7, 2015

Last Updated

April 30, 2020

Record last verified: 2020-04