NCT03879499

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

March 12, 2019

Last Update Submit

July 17, 2024

Conditions

Keywords

cuff hematomaCRP levels

Outcome Measures

Primary Outcomes (2)

  • Relationship between CRP Levels and cuff hematoma; crp levels

    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

    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

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women who underwent TLH operation with benign gynecological indications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 18, 2019

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 18, 2024

Record last verified: 2024-07