Relationship Between Constipation and Inguinal Hernia

April 22, 2016 updated by: Abdulcabbar Kartal, Siverek Devlet Hastanesi

Impact of Chronic Constipation on the Development Inguinal Hernia

The purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale.

Study Overview

Status

Completed

Detailed Description

Causes of inguinal hernia are known to be multifactorial, although not fully understood. Besides family history, and connective tissue diseases, the sudden increase in abdominal pressure as heavy lifting, chronic constipation , coughing, straining , situations such as difficulty urinating facilitate the formation and emergence of hernia.

Constipation severity scale(CSS) was developed by Varma et al in 2008. CSS is a scale to determine the individuals defecation frequency, the intensity and difficulty during defecation.CSS has three subscales including Pain, Congestion stool and Large Intestine laziness(0-73 points).High scores indicate that serious symptoms.

Investigators found no studies that show how constipation impact on groin hernias. Investigators are planning to understand the effect of constipation on direct and indirect hernia formation.

Study Type

Observational

Enrollment (Actual)

200

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 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy volunteers

Description

Inclusion Criteria:

  • healthy volunteers(n:100)
  • patients above age of 18(n:100)
  • patients with groin hernia(n:100)

Exclusion Criteria:

  • previous inguinal hernia surgery
  • patients who did not accept the procedure
  • patients under age of 18

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
constipation & hernia group
The effect of constipation on study group whether there is a correlation between subgroups of operated patients on the view of direct and indirect hernias(Nyhuss classification).
constipation & normal population
The level of constipation on normal population using constipation severity scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of chronic constipation on the development inguinal hernia
Time Frame: 12 months
This study asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale(CSS). After the Ethics Committee Approval from Harran University, study was carried out with 200 patient. After filling out a detailed consent form the two groups were asked to fill out the scale(study group: 100 Patients which were operated with the diagnosis of inguinal hernia, control group: 100 volunteers clinically determined to be healthy). . During surgery, hernia types of the patient's in study group defined according to Nyhus classification and noted on the scale. Results in both groups were studied to understand the effect of constipation on development of inguinal hernia and whether there was a correlation between surgical patients and healthy volunteers. The effect of constipation was also evaluated on operated patients on the view of direct and indirect hernias. P <0.05 was considered significant.,
12 months

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Ali Uzunköy, Harran University
  • Study Director: Bülent Çitgez, Sisli Etfal Hospital

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

January 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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