CClinicalTrials.gg
Status unknownNCT04785430Updated Mar 5, 2021

Incarceration Risk Factors in Inguinal Hernia.

An observational study in Incarcerated Inguinal Hernia, Strangulated Inguinal Hernia and Inguinal Hernia, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Incarcerated Inguinal Hernia
  • Strangulated Inguinal Hernia
  • Inguinal Hernia
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Younger than 18, older than 80
  • Pregnancy
  • Mental retardation
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Hernia defect size

    Measurement of fascial defect causing the hernia, using USG or CT

    Time frame: 2 hours after physical examination

Secondary outcomes

  1. Constipation

    Frequent episodes without defecation lasting more than 3 days

    Time frame: 1 years

  2. Age

    Patients age

    Time frame: up to 24 weeks

  3. Body Mass Index

    Patients weight in kilograms divided by the square of height in meters.

    Time frame: up to 24 weeks

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Study locations

1 site
  • Bakırkoy Dr.Sadi Konuk Training and Research Hospital
    Istanbul, Turkey
08

References and documents

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. PubMed 30980102 ↗
  • 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. PubMed 31701494 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04785430
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Turgut Donmez (Bakirkoy EAH, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Mar 5, 2021
Start date
Jan 1, 2021
Primary completion
Aug 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Mar 5, 2021

Study contacts

Turgut Donmez
study director · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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