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Completed

NCT Number: NCT04366375

Pentraxin-3 in Hysterectomy Patients

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

Acute trauma and major surgeries activate a series of cascades to evoke systemic inflammatory response. The magnitude of the resulting inflammatory response is proportional to the severity of the tissue trauma. Abdominal or laparoscopic technique is widely used for the purpose of hysterectomy surgery. It is crucial for many aspects to compare these two techniques of hysterectomy in terms of the surgery-induced trauma.

In this study, the severity of the inflammatory response resulting from the tissue trauma due to the techniques of TLH+BSO and TAH+BSO applied in our department were compared based on the PTX-3 molecule.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

·TLH+BSO patients and TAH+BSO patients

Exclusion criteria

  • 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).

Treatment and study plan

PTX-3

Diagnostic 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.

Primary outcomes

  1. Pentraxin-3 level

    Time frame: Before 24 hours preoperatively and upto 24 hours postoperatively

    Pentraxin-3 ng/mL

Secondary outcomes

  1. (NLR)

    Time frame: Up to 24 hours postoperative

    neutrophile/lymphocyte ratio

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2020
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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