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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03937739
Other study ID # Hernia nutrition
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date April 1, 2019

Study information

Verified date May 2019
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are lots of inguinal hernia risk factors determined in the literature. But the relationship between nutritional status and inguinal hernia were not examined yet. In this study the investigators evaluated the constipation scale and food consumption of the inguinal hernia patients. This Case-Control study was performed between March 2018- March 2019. The patients who admitted for operation with inguinal hernia were the case group (n:115) and the patients who were admitted to the same hospital without inguinal hernia were control group (n:88). The age, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the Wexner constipation scoring were examined using questionnaire were noted.


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.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date April 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
Nutritional and constipation questionnaire
Alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all. were examined using questionnaire

Locations

Country Name City State
Turkey Istanbul Training and Research Hospital Istanbul
Turkey Istanbul University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul University Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional frequency 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
Primary Physical activity Regular physical activity (minute/week) 1 week
Primary Smoking and alcohol use Number of daily cigarette usage Glass of daily alcohol use 1 week
Secondary Constipation scoring 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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