Postoperative CRP Levels and Vaginal Cuff Hematoma

March 16, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

The Value of Postoperative CRP Levels to Predict Postoperative Vaginal Cuff Hematoma

After laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative CRP value to help predict the other complications.

A total of 136 patients who underwent total laparoscopic hysterectomy (TLH) were evaluated. CRP, White blood cell (WBC) and hemoglobin values (Hb) were measured on the 1st, 2nd and 7th days before and after the operation. Complications, pre-postoperative vaginal length and female sexual function were evaluated. Fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (ROC) curve. ROC curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women who underwent TLH operation with benign gynecological indications

Description

Inclusion Criteria:women who underwent TLH operation with benign gynecological indications

Exclusion Criteria:

  • Decided to switch to laparotomy during operation
  • postoperative complication due to relaparotomy
  • infection (including urinary system and lung infections)
  • Blood transfusion after TLH
  • with rheumatic diseases
  • length of hospital stay due to wound infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between CRP Levels and cuff hematoma; crp levels
Time Frame: 1 week
The value of Postoperative CRP Levels to predict Postoperative Vaginal Cuff Hematoma ; To evaluate tissue trauma and surgical inflammatory responses, venous peripheral blood samples (C-reactive protein) were taken on the first, second and seventh day postoperatively. CRP values were measured under standardized conditions using turbidometry. CRP levels (mg / dl) were recorded.
1 week
Relationship between CRP Levels and cuff hematoma; cuff hematoma measurement
Time Frame: 15 days
The patients were called to the outpatient clinic after the hysterectomy and evaluated by transvaginal ultrasonography (tvusg) for cuff hematoma.hematoma dimensions recorded in centimeters.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 16, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/78

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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