- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937739
Nutrition and Constipation at Inguinal Hernia Patients
Nutritional Status and Constipation Scoring for Inguinal Hernia Patients; A Case-Control Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inguinal hernia is the most common type of abdominal wall hernias and the prevalence is estimated as 5-10% in United States. Although many risk factors have been defined for inguinal hernia, family history of inguinal hernia has been reported to be one of the most important factors. In addition to this, advanced age, male gender, smoking, chronic cough causing intraabdominal pressure increase, and chronic constipation are the risk factors. The hernias may recur according to the causes they originate from the reasons they originate in the early or late period after treatment.In this study, constipation and nutritional status of inguinal hernia patients were evaluated and it was aimed to examine the relationship between inguinal hernia and nutrition which has not been previously evaluated in the literature.
This Case-Control study was performed between March 2018- March 2019. The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study (n:115). Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group (n:88).
Written informed consent was obtained from each participant. The numbers of cases and controls were matched based gender and age in each group. The age, gender, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Wexner constipation scoring were examined using questionnaire. The demographic data, nutritional status and the constipation scores were compared among individuals to identify differences between these two groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34093
- Istanbul University
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Istanbul, Turkey, 34098
- Istanbul Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of Inguinal Hernia
Exclusion Criteria:
- Cancer
- Pregnancy
- Chronic liver diseases
- Previous abdominal surgery history
- Femoral hernia
- Bilateral inguinal hernia
- Weight loss above the 20% of the body weight in the last 6 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1: Case group,
The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study.
|
Alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all.
were examined using questionnaire
|
Group 2: Control group,
The patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group.
|
Alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all.
were examined using questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional frequency
Time Frame: 1 week
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Food consumption questionnaire with; Daily cheese consumption (gram) Daily red meat consumption (gram) Daily chicken consumption (gram) Daily fish consumption (gram) Daily salami- sausage consumption (gram) Daily giblets (Liver, kidney etc.) consumption (gram) Daily egg consumption (gram) Daily nuts consumption (gram) Daily legumes consumption (gram) Daily bread consumption (gram) Daily rice-pasta consumption (gram) Daily vegetable consumption (gram) Daily fruit consumption (gram) Daily fastfood consumption (gram) |
1 week
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Physical activity
Time Frame: 1 week
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Regular physical activity (minute/week)
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1 week
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Smoking and alcohol use
Time Frame: 1 week
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Number of daily cigarette usage Glass of daily alcohol use
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constipation scoring
Time Frame: 1 week
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Constipation scoring according to Wexner constipation scale with a 8 question questionnaire. First seven questions have 0 to 4 point and the last question has 0 to 2 point in the scoring system. All of these points summed and the minimum and maximum total score is 0 to 30. In this scoring system total score which is above 15 point is significant for constipation. |
1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Cemile Idiz, Ph.D, Itanbul University
Publications and helpful links
General Publications
- Dabbas N, Adams K, Pearson K, Royle G. Frequency of abdominal wall hernias: is classical teaching out of date? JRSM Short Rep. 2011 Jan 19;2(1):5. doi: 10.1258/shorts.2010.010071.
- Burcharth J, Pommergaard HC, Rosenberg J. The inheritance of groin hernia: a systematic review. Hernia. 2013 Apr;17(2):183-9. doi: 10.1007/s10029-013-1060-4. Epub 2013 Feb 20.
- Kartal A, Yalcin M, Citgez B, Uzunkoy A. The effect of chronic constipation on the development of inguinal herniation. Hernia. 2017 Aug;21(4):531-535. doi: 10.1007/s10029-017-1604-0. Epub 2017 Apr 9.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hernia nutrition
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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