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Relationship Between Constipation and Inguinal Hernia

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

Tracking Information
First Submitted Date October 23, 2015
First Posted Date April 25, 2016
Last Update Posted Date April 25, 2016
Study Start Date January 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2016)
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.,
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Constipation and Inguinal Hernia
Official Title Impact of Chronic Constipation on the Development Inguinal Hernia
Brief Summary The purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale.
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 [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy volunteers
Condition
  • Inguinal Hernia
  • Constipation
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2016)
200
Original Actual Enrollment Same as current
Actual Study Completion Date September 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02749682
Other Study ID Numbers 74059997.050.01.04/78
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abdulcabbar Kartal, Siverek Devlet Hastanesi
Study Sponsor Siverek Devlet Hastanesi
Collaborators Harran University
Investigators
Study Director: Ali Uzunköy Harran University
Study Director: Bülent Çitgez Şişli Etfal Hospital
PRS Account Siverek Devlet Hastanesi
Verification Date April 2016