NutritionNCT03937739
Nutrition and Constipation at Inguinal Hernia Patients
An observational study of Nutrition and Constipation, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
There are lots of inguinal hernia risk factors determined in the literature. But the relationship between nutritional status and inguinal hernia were not examined yet. In this study the investigators evaluated the constipation scale and food consumption of the inguinal hernia patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition, Constipation, Inguinal Hernia
- What is being tested?
- Nutritional and constipation questionnaire
- How many people
- 203 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Apr 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study. Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group.
Who may be able to join
- Clinical diagnosis of Inguinal Hernia
Who cannot join
- Cancer
- Pregnancy
- Chronic liver diseases
- Previous abdominal surgery history
- Femoral hernia
- Bilateral inguinal hernia
- Weight loss above the 20% of the body weight in the last 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University
Istanbul, 34093
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Nutritional Status and Constipation Scoring for Inguinal Hernia Patients; A Case-Control Study.
There are lots of inguinal hernia risk factors determined in the literature. But the relationship between nutritional status and inguinal hernia were not examined yet. In this study the investigators evaluated the constipation scale and food consumption of the inguinal hernia patients. This Case-Control study was performed between March 2018- March 2019. The patients who admitted for operation with inguinal hernia were the case group (n:115) and the patients who were admitted to the same hospital without inguinal hernia were control group (n:88). The age, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the Wexner constipation scoring were examined using questionnaire were noted.
Read the detailed description
Inguinal hernia is the most common type of abdominal wall hernias and the prevalence is estimated as 5-10% in United States. Although many risk factors have been defined for inguinal hernia, family history of inguinal hernia has been reported to be one of the most important factors. In addition to this, advanced age, male gender, smoking, chronic cough causing intraabdominal pressure increase, and chronic constipation are the risk factors. The hernias may recur according to the causes they originate from the reasons they originate in the early or late period after treatment.In this study, constipation and nutritional status of inguinal hernia patients were evaluated and it was aimed to examine the relationship between inguinal hernia and nutrition which has not been previously evaluated in the literature.
This Case-Control study was performed between March 2018- March 2019. The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study (n:115). Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group (n:88).
Written informed consent was obtained from each participant. The numbers of cases and controls were matched based gender and age in each group. The age, gender, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Wexner constipation scoring were examined using questionnaire. The demographic data, nutritional status and the constipation scores were compared among individuals to identify differences between these two groups.
- Conditions
- Nutrition, Constipation, Inguinal Hernia
- Being tested
- Nutritional and constipation questionnaire
- Keywords
- Nutrition, Constipation, Hernia
- Medical subject headings
- Constipation, Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and constipation questionnaireOther
Alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all. were examined using questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Case group, | The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study. Receives: Other: Nutritional and constipation questionnaire | |
| Group 2: Control group, | The patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group. Receives: Other: Nutritional and constipation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional frequency
Food consumption questionnaire with;
Daily cheese consumption (gram) Daily red meat consumption (gram) Daily chicken consumption (gram) Daily fish consumption (gram) Daily salami- sausage consumption (gram) Daily giblets (Liver, kidney etc.) consumption (gram) Daily egg consumption (gram) Daily nuts consumption (gram) Daily legumes consumption (gram) Daily bread consumption (gram) Daily rice-pasta consumption (gram) Daily vegetable consumption (gram) Daily fruit consumption (gram) Daily fastfood consumption (gram)
Measured: 1 week
Physical activity
Regular physical activity (minute/week)
Measured: 1 week
Smoking and alcohol use
Number of daily cigarette usage Glass of daily alcohol use
Measured: 1 week
Secondary outcomes (1)
Constipation scoring
Constipation scoring according to Wexner constipation scale with a 8 question questionnaire.
First seven questions have 0 to 4 point and the last question has 0 to 2 point in the scoring system. All of these points summed and the minimum and maximum total score is 0 to 30. In this scoring system total score which is above 15 point is significant for constipation.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Responsible party
- Principal investigator, Cemile Idiz, Istanbul University
- Investigators
- Cemile Idiz, Ph.D, Study director, Itanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937739
- Sponsor's protocol ID
- Hernia nutrition
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If any researcher want to use our data for metaanalysis we can share.
Publications
Dabbas N, Adams K, Pearson K, Royle G. Frequency of abdominal wall hernias: is classical teaching out of date? JRSM Short Rep. 2011 Jan 19;2(1):5. doi: 10.1258/shorts.2010.010071.
PubMed 21286228Burcharth J, Pommergaard HC, Rosenberg J. The inheritance of groin hernia: a systematic review. Hernia. 2013 Apr;17(2):183-9. doi: 10.1007/s10029-013-1060-4. Epub 2013 Feb 20.
PubMed 23423330Kartal A, Yalcin M, Citgez B, Uzunkoy A. The effect of chronic constipation on the development of inguinal herniation. Hernia. 2017 Aug;21(4):531-535. doi: 10.1007/s10029-017-1604-0. Epub 2017 Apr 9.
PubMed 28393306
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Constipation Scoring for Inguinal Hernia Patients; A Case-Control Study.
- ClinicalTrials.gov ID
- NCT03937739
- Acronym / sponsor ID
- Hernia nutrition
- Conditions
- Nutrition, Constipation, Inguinal Hernia
- Keywords
- Nutrition, Constipation, Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 May 2019 (actual)
- 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.
There are lots of inguinal hernia risk factors determined in the literature. But the relationship between nutritional status and inguinal hernia were not examined yet. In this study the investigators evaluated the constipation scale and food consumption of the inguinal hernia patients. This Case-Control study was performed between March 2018- March 2019. The patients who admitted for operation with inguinal hernia were the case group (n:115) and the patients who were admitted to the same hospital without inguinal hernia were control group (n:88). The age, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the Wexner constipation scoring were examined using questionnaire were noted.
Detailed description
Inguinal hernia is the most common type of abdominal wall hernias and the prevalence is estimated as 5-10% in United States. Although many risk factors have been defined for inguinal hernia, family history of inguinal hernia has been reported to be one of the most important factors. In addition to this, advanced age, male gender, smoking, chronic cough causing intraabdominal pressure increase, and chronic constipation are the risk factors. The hernias may recur according to the causes they originate from the reasons they originate in the early or late period after treatment.In this study, constipation and nutritional status of inguinal hernia patients were evaluated and it was aimed to examine the relationship between inguinal hernia and nutrition which has not been previously evaluated in the literature.
This Case-Control study was performed between March 2018- March 2019. The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study (n:115). Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group (n:88).
Written informed consent was obtained from each participant. The numbers of cases and controls were matched based gender and age in each group. The age, gender, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Wexner constipation scoring were examined using questionnaire. The demographic data, nutritional status and the constipation scores were compared among individuals to identify differences between these two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Case group, | – | Other: Nutritional and constipation questionnaireThe patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study. |
| Group 2: Control group, | – | Other: Nutritional and constipation questionnaireThe patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study. Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Inguinal Hernia
Key exclusion criteria (7 listed)
- Cancer
- Pregnancy
- Chronic liver diseases
- Previous abdominal surgery history
- Femoral hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and constipation questionnaireAlcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all. were examined using questionnaire | Other | Group 1: Case group,, Group 2: Control group, |
Primary outcome
Nutritional frequency
Time frame: 1 week
Food consumption questionnaire with; Daily cheese consumption (gram) Daily red meat consumption (gram) Daily chicken consumption (gram) Daily fish consumption (gram) Daily salami- sausage consumption (gram) Daily giblets (Liver, kidney etc.) consumption (gram) Daily egg consumption (gram) Daily nuts consumption (gram) Daily legumes consumption (gram) Daily bread consumption (gram) Daily rice-pasta consumption (gram) Daily vegetable consumption (gram) Daily fruit consumption (gram) Daily fastfood consumption (gram)
Physical activity
Time frame: 1 week
Regular physical activity (minute/week)
Smoking and alcohol use
Time frame: 1 week
Number of daily cigarette usage Glass of daily alcohol use
1 secondary outcome
Constipation scoring
Time frame: 1 week
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 6 May 2019.
- Results publication: PubMed 21286228Dabbas N, Adams K, Pearson K, Royle G. Frequency of abdominal wall hernias: is classical teaching out of date? JRSM Short Rep. 2011 Jan 19;2(1):5. doi: 10.1258/shorts.2010.010071.
- Results publication: PubMed 23423330Burcharth J, Pommergaard HC, Rosenberg J. The inheritance of groin hernia: a systematic review. Hernia. 2013 Apr;17(2):183-9. doi: 10.1007/s10029-013-1060-4. Epub 2013 Feb 20.
- Results publication: PubMed 28393306Kartal A, Yalcin M, Citgez B, Uzunkoy A. The effect of chronic constipation on the development of inguinal herniation. Hernia. 2017 Aug;21(4):531-535. doi: 10.1007/s10029-017-1604-0. Epub 2017 Apr 9.
- Nutritional suggestions for hernia patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If any researcher want to use our data for metaanalysis we can share.
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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.
Cemile Idiz, Ph.D study director
Itanbul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition and Constipation, run by Istanbul University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 7 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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Nutritional frequency (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937739, which also lists 3 linked publications.
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 6 May 2019.