Nutrition and Constipation at Inguinal Hernia Patients

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03937739
Collaborator
Istanbul Training and Research Hospital (Other)
203
2
13
101.5
7.8

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Mar 1, 2018
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Nutritional frequency [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 [1 week]

    Regular physical activity (minute/week)

  3. Smoking and alcohol use [1 week]

    Number of daily cigarette usage Glass of daily alcohol use

Secondary Outcome Measures

  1. Constipation scoring [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Istanbul Turkey 34093
2 Istanbul Training and Research Hospital Istanbul Turkey 34098

Sponsors and Collaborators

  • Istanbul University
  • Istanbul Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Cemile Idiz, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier:
NCT03937739
Other Study ID Numbers:
  • Hernia nutrition
First Posted:
May 6, 2019
Last Update Posted:
May 6, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cemile Idiz, Principal Investigator, Istanbul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2019