Incarceration Risk Factors in Inguinal Hernia.

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04785430
• Other study ID #: BakirkoyEAH Hande1
• Status: Enrolling by invitation
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2021
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Incarcerated Inguinal Hernia
• Inguinal Hernia
• Strangulated Inguinal Hernia

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr.Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia defect size	Measurement of fascial defect causing the hernia, using USG or CT	2 hours after physical examination
Secondary	Constipation	Frequent episodes without defecation lasting more than 3 days	1 years
Secondary	Age	Patients age	up to 24 weeks
Secondary	Body Mass Index	Patients weight in kilograms divided by the square of height in meters.	up to 24 weeks