Management of Tubo-ovarian Abscess: a Single Center Exper... | NCT04817631

Studies
Management of Tubo-ovarian Abscess: a Single Center Experience

NCT04817631

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Status

Completed

Last Update Posted

Mar 26, 2021Actual

Enrollment

82Actual

Phase

Not provided

Conditions

Tubo-ovarian Abscess

Interventions

tuboovarian abscess

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Mar 14, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nura Fitnat Topbas Selcuki, MD, Specialist in Obstetrics and Gynecology, Sisli Hamidiye Etfal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Sisli Hamidiye Etfal Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities.

Detailed Description

This retrospective study is conducted at Health Sciences University Turkey, Sisli Hamidiye Etfal Training and Research Hospital Department of Obstetrics and Gynecology. Electronic database was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities. A change in management strategy over the years if any will be reported.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tuboovarian abscess	Other	Evaluating the surgical and medical management of tuboovarian abscess

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluating the management of tuboovarian abscess on the basis of surgical or medical modalities by assessing hospitalization duration and recurrence	Patients' demographics data (age, gravity, parity, presence of additional comorbidities and BMI) will be recorded. Their laboratory assessment of infection prior to treatment begin such as CRP an procalcitonin will be recorded. Their treatment modalities in terms of surgery or antibiothepry, duration of hospitalization and recurrence will be recorded. Statistical analysis will be done using SPSS. Student's t test will be used for comparison where necessary. Significance will be evaluated using p-value.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

presence of a pelvic mass > 3 cm with transvaginal ultrasound or magnetic resonance imaging indication abscess
cervical and uterine tenderness
abdominal rebound-defense under physical examination indication peritoneal irritation
presence of symptoms such as fever, pelvic pain and increase in laboratory infection parameters

Exclusion Criteria:

Patients with known malignities
Patients with incomplete data in the clinic's electronic database
Patients who continued their treatment at other centers

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

the study will be conducted on female patients with tuboovarian abscess

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women over 18 years of age who presented to our clinic with symptoms of infection and where tuboovarian abscess was suspected with physical and ultrasonographic examination are included in this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Hamidiye Etfal Training and Research Hospital		Istanbul		34371	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided