NCT03756909

Brief Summary

The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 27, 2018

Last Update Submit

November 28, 2018

Conditions

AnesthesiaComplication

Outcome Measures

Primary Outcomes (2)

  • The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN

    Pain level will be evaluated by using CHEOPS (Children's Hospital of Eastern Ontario Pain Scale ) pain score. The scale includes six categories of pain behavior (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the total score ranges between 4 and 13.

    Postoperative 6 hours

  • The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN

    Pain level will be evaluated by using POVN score. Evaluation of nausea and vomiting was performed by a four-point scale; 0: No nausea and/or vomiting, 1: mild nausea and/or vomiting which does not require treatment, 2: nausea and/or vomiting requiring treatment and 3: vomiting resistant to antiemetic treatment

    Postoperative 6 hours

Study Arms (2)

adenoidectomy group

Operations of adenoidectomy

adenotonsillectomy group

Operations of adenotonsillectomy

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

2-10 years

You may qualify if:

  • Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia

You may not qualify if:

  • Immunodeficiency
  • Children of parents who do not want to participate in the study
  • Use of anticoagulants
  • Children with hematological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof. MD

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

February 1, 2018

Primary Completion

June 30, 2018

Study Completion

November 1, 2018

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

TU(1)