Incarceration Risk Factors in Inguinal Hernia.

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inguinal Hernia; Strangulated Inguinal Hernia; Incarcerated 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bakırkoy Dr.Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia defect size	Measurement of fascial defect causing the hernia, using USG or CT	2 hours after physical examination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Study Director: Turgut Donmez, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Publications and helpful links

General Publications

• Sneiders D, Yurtkap Y, Kroese LF, Kleinrensink GJ, Lange JF, Gillion JF; Hernia-Club Members. Risk Factors for Incarceration in Patients with Primary Abdominal Wall and Incisional Hernias: A Prospective Study in 4472 Patients. World J Surg. 2019 Aug;43(8):1906-1913. doi: 10.1007/s00268-019-04989-x.
• Kunduz E, Sormaz IC, Yapalak Y, Bektasoglu HK, Gok AF. Comparison of surgical techniques and results for emergency or elective femoral hernia repair. Ulus Travma Acil Cerrahi Derg. 2019 Nov;25(6):611-615. doi: 10.14744/tjtes.2019.04524.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: BakirkoyEAH Hande1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No