Relationship Between Constipation and Inguinal Hernia

• ClinicalTrials.gov Identifier: NCT02749682
• Recruitment Status: Completed
• First Posted: April 25, 2016
• Last Update Posted: April 25, 2016
• Sponsor: Siverek Devlet Hastanesi
• Collaborator: Harran University
• Information provided by (Responsible Party): Abdulcabbar Kartal, Siverek Devlet Hastanesi

Study Description

Brief Summary:

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

Condition or disease
Inguinal Hernia; Constipation

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Official Title: Impact of Chronic Constipation on the Development Inguinal Hernia
• Study Start Date: January 2015
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: September 2015

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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.,

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 78 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Siverek Devlet Hastanesi

Harran University

Investigators

• Study Director: Ali Uzunköy; Harran University
• Study Director: Bülent Çitgez; Şişli Etfal Hospital

More Information

Additional Information:

• Responsible Party: Abdulcabbar Kartal, Principal Investigator, Siverek Devlet Hastanesi
• ClinicalTrials.gov Identifier: NCT02749682
• Other Study ID Numbers: 74059997.050.01.04/78
• First Posted: April 25, 2016
• Last Update Posted: April 25, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Abdulcabbar Kartal, Siverek Devlet Hastanesi:

Nyhus classification; constipation severity scale; groin hernia

Additional relevant MeSH terms:

Hernia; Constipation; Hernia, Inguinal; Pathological Conditions, Anatomical; Signs and Symptoms, Digestive; Hernia, Abdominal