NCT02749682

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

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

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

October 23, 2015

Last Update Submit

April 22, 2016

Conditions

Keywords

Nyhus classificationconstipation severity scalegroin hernia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, InguinalConstipation

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Ali Uzunköy

    Harran University

    STUDY DIRECTOR
  • Bülent Çitgez

    Şişli Etfal Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 23, 2015

First Posted

April 25, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

April 25, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share