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Nutrition and Constipation at Inguinal Hernia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937739
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Istanbul Training and Research Hospital
Information provided by (Responsible Party):
Cemile Idiz, Istanbul University

Brief 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.

Condition or disease Intervention/treatment
Nutrition Constipation Inguinal Hernia Other: Nutritional and constipation questionnaire

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.

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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Nutritional Status and Constipation Scoring for Inguinal Hernia Patients; A Case-Control Study.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation Hernia

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.
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

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.
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




Primary Outcome Measures :
  1. Nutritional frequency [ Time Frame: 1 week ]

    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)


  2. Physical activity [ Time Frame: 1 week ]
    Regular physical activity (minute/week)

  3. Smoking and alcohol use [ Time Frame: 1 week ]
    Number of daily cigarette usage Glass of daily alcohol use


Secondary Outcome Measures :
  1. Constipation scoring [ Time Frame: 1 week ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study. 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937739


Locations
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Turkey
Istanbul University
Istanbul, Turkey, 34093
Istanbul Training and Research Hospital
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul University
Istanbul Training and Research Hospital
Investigators
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Study Director: Cemile Idiz, Ph.D Itanbul University
Additional Information:
Publications of Results:
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Responsible Party: Cemile Idiz, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03937739    
Other Study ID Numbers: Hernia nutrition
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If any researcher want to use our data for metaanalysis we can share.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cemile Idiz, Istanbul University:
Nutrition
Constipation
Hernia
Additional relevant MeSH terms:
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Hernia
Constipation
Hernia, Inguinal
Pathological Conditions, Anatomical
Signs and Symptoms, Digestive
Signs and Symptoms
Hernia, Abdominal