Inguinal HerniaNCT02749682
Relationship Between Constipation and Inguinal Hernia
An observational study of Inguinal Hernia and Constipation, run by Siverek Devlet Hastanesi.
Trial summary
The purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using Constipation Severity Scale. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Constipation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy volunteers
Who may be able to join
- healthy volunteers(n:100)
- patients above age of 18(n:100)
- patients with groin hernia(n:100)
Who cannot join
- previous inguinal hernia surgery
- patients who did not accept the procedure
- patients under age of 18
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia, Constipation
- Keywords
- Nyhus classification, constipation severity scale, groin hernia
- Medical subject headings
- Hernia, Inguinal, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Siverek Devlet Hastanesi
- Sponsor type
- University, hospital or other
- Collaborators
- Harran University
- Responsible party
- Principal investigator, Abdulcabbar Kartal, Siverek Devlet Hastanesi
- Investigators
- Ali Uzunköy, Study director, Harran UniversityBülent Çitgez, Study director, Şişli Etfal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749682
- Sponsor's protocol ID
- 74059997.050.01.04/78
- Status last verified
- Apr 2016
- First submitted
- 23 Oct 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Constipation on the Development Inguinal Hernia
- ClinicalTrials.gov ID
- NCT02749682
- Acronym / sponsor ID
- 74059997.050.01.04/78
- Conditions
- Inguinal Hernia, Constipation
- Keywords
- Nyhus classification, constipation severity scale, groin hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Siverek Devlet HastanesiUniversity, hospital or other
- Collaborators
- Harran University
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- study group: 100 patients with groin hernia above age of 18 kontrol group: 100 healthy volunteers
Key inclusion criteria (3 listed)
- healthy volunteers(n:100)
- patients above age of 18(n:100)
- patients with groin hernia(n:100)
Key exclusion criteria (3 listed)
- previous inguinal hernia surgery
- patients who did not accept the procedure
- patients under age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Uzunköy study director
Harran University
Bülent Çitgez study director
Şişli Etfal Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Constipation, run by Siverek Devlet Hastanesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of chronic constipation on the development inguinal hernia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.