Nutrition and Constipation at Inguinal Hernia Patients

May 2, 2019 updated by: Cemile Idiz, Istanbul University

Nutritional Status and Constipation Scoring for Inguinal Hernia Patients; A Case-Control Study.

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.

Study Overview

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

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34093
        • Istanbul University
      • Istanbul, Turkey, 34098
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Physical activity
Time Frame: 1 week
Regular physical activity (minute/week)
1 week
Smoking and alcohol use
Time Frame: 1 week
Number of daily cigarette usage Glass of daily alcohol use
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Cemile Idiz, Ph.D, Itanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If any researcher want to use our data for metaanalysis we can share.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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