Relationship Between Constipation and Inguinal Hernia

Constipation Clinical Trial

Official title:

Impact of Chronic Constipation on the Development Inguinal Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749682
• Other study ID #: 74059997.050.01.04/78
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: April 22, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Siverek Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Siverek Devlet Hastanesi	Harran University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of chronic constipation on the development inguinal hernia	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	Yes