- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02749682
Relationship Between Constipation and Inguinal Hernia
Impact of Chronic Constipation on the Development Inguinal Hernia
Study Overview
Status
Conditions
Detailed Description
Causes of inguinal hernia are known to be multifactorial, although not fully understood. Besides family history, and connective tissue diseases, the sudden increase in abdominal pressure as heavy lifting, chronic constipation , coughing, straining , situations such as difficulty urinating facilitate the formation and emergence of hernia.
Constipation severity scale(CSS) was developed by Varma et al in 2008. CSS is a scale to determine the individuals defecation frequency, the intensity and difficulty during defecation.CSS has three subscales including Pain, Congestion stool and Large Intestine laziness(0-73 points).High scores indicate that serious symptoms.
Investigators found no studies that show how constipation impact on groin hernias. Investigators are planning to understand the effect of constipation on direct and indirect hernia formation.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthy volunteers(n:100)
- patients above age of 18(n:100)
- patients with groin hernia(n:100)
Exclusion Criteria:
- previous inguinal hernia surgery
- patients who did not accept the procedure
- patients under age of 18
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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constipation & hernia group
The effect of constipation on study group whether there is a correlation between subgroups of operated patients on the view of direct and indirect hernias(Nyhuss classification).
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constipation & normal population
The level of constipation on normal population using constipation severity scale.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of chronic constipation on the development inguinal hernia
Time Frame: 12 months
|
This study asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale(CSS).
After the Ethics Committee Approval from Harran University, study was carried out with 200 patient.
After filling out a detailed consent form the two groups were asked to fill out the scale(study group: 100 Patients which were operated with the diagnosis of inguinal hernia, control group: 100 volunteers clinically determined to be healthy). .
During surgery, hernia types of the patient's in study group defined according to Nyhus classification and noted on the scale.
Results in both groups were studied to understand the effect of constipation on development of inguinal hernia and whether there was a correlation between surgical patients and healthy volunteers.
The effect of constipation was also evaluated on operated patients on the view of direct and indirect hernias.
P <0.05 was considered significant.,
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ali Uzunköy, Harran University
- Study Director: Bülent Çitgez, Sisli Etfal Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 74059997.050.01.04/78
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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