NCT03937739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

April 30, 2019

Last Update Submit

May 2, 2019

Conditions

Keywords

NutritionConstipationHernia

Outcome Measures

Primary Outcomes (3)

  • 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

  • Physical activity

    Regular physical activity (minute/week)

    1 week

  • Smoking and alcohol use

    Number of daily cigarette usage Glass of daily alcohol use

    1 week

Secondary Outcomes (1)

  • Constipation scoring

    1 week

Study Arms (2)

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

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

Interventions

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

Group 1: Case group,Group 2: Control group,

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Clinical diagnosis of Inguinal Hernia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

Related Links

MeSH Terms

Conditions

ConstipationHernia, InguinalHernia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsHernia, AbdominalPathological Conditions, Anatomical

Study Officials

  • Cemile Idiz, Ph.D

    Itanbul University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 6, 2019

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations