Incarceration Risk Factors in Inguinal Hernia.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04785430

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

Condition or Disease	Intervention/Treatment	Phase
Incarcerated Inguinal Hernia Strangulated Inguinal Hernia Inguinal Hernia

Detailed Description

A prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Incarceration Risk Factors in Inguinal Hernia.Prospective Observational Clinical Trial.

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients who underwent elective inguinal hernia surgery Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia and underwent hernia repair surgery.
Patients who underwent emergency inguinal hernia surgery Patients who have applied to the emergency clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Outcome Measures

Primary Outcome Measures

Hernia defect size [2 hours after physical examination]
Measurement of fascial defect causing the hernia, using USG or CT

Secondary Outcome Measures

Constipation [1 years]
Frequent episodes without defecation lasting more than 3 days
Age [up to 24 weeks]
Patients age
Body Mass Index [up to 24 weeks]
Patients weight in kilograms divided by the square of height in meters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages between 18-80
Primary and recurrent inguinal hernias
Incarcerated / strangulated inguinal hernias

Exclusion Criteria:

Younger than 18, older than 80
Pregnancy
Mental retardation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakırkoy Dr.Sadi Konuk Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

Study Director: Turgut Donmez, Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Turgut Donmez, Bakirkoy EAH, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

ClinicalTrials.gov Identifier:

NCT04785430

Other Study ID Numbers:

BakirkoyEAH Hande1

First Posted:

Mar 5, 2021

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hernia

Hernia, Inguinal

Study Results

No Results Posted as of Mar 5, 2021