HemorrhoidsNCT03444389
The Relationship Between Hemorrhoids and Smartphone Use in the Lavatory
An observational study of Hemorrhoids, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to examine the relationship between hemorrhoids, a common complaint, and the use of smartphones, also a common feature of modern life, in the lavatory. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- How many people
- 1,798 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Jun 2018
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.
Who may be able to join
- The study group consists of people with hemorrhoids.
- The control group consists of healthy participants without hemorrhoids.
- The study and control groups should have similar habits in terms of lifestyle, eating habits, etc.
Who cannot join
- The control group participants should have no vision, hearing, or other problems that restrict or otherwise affect their use of smartphones (the risk factor).
- Participants should not have health problems that may be a causative factor in the pathogenesis of hemorrhoids.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yuzuncu Yil University Faculty of Medicine
Van, 65080
Sebahattin Celik, M.D., 90 432 4445065 ext. 26099, scelik@yyu.edu.tr
About this study
Official title: An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory
The objective of this study is to examine the relationship between hemorrhoids, a common complaint, and the use of smartphones, also a common feature of modern life, in the lavatory.
As is known, hemorrhoidal disease is a frequently observed disease of the lower rectum and anal region that seriously impairs the patient's quality of life.
Based on clinical observations, the study investigators have found that the use of mobile phones in the lavatory has become a habit for some people. The investigators surmise that this habit, which increases the time spent on the toilet, also leads to an increase in pressure on the anal region and straining during defecation. There is a gap in the literature investigating the relationship between these two situations (smartphone use in the lavatory and the development of hemorrhoids). The basic research question of the present study is thus designed to determine to what extent the use of smartphones increases time spent in the lavatory and whether there is an association between this increase in time and hemorrhoidal disease.
Read the detailed description
The objective of this study is to examine the relationship between hemorrhoids, a common complaint, and the use of smartphones, also a common feature of modern life, in the lavatory.
As is known, hemorrhoidal disease is a frequently observed disease of the lower rectum and anal region that seriously impairs the patient's quality of life. The underlying pathophysiological event is vascular enlargement of the lower rectum. Hemorrhoids are classified as internal or external, and it is assumed that the same pathological mechanisms operate in both types. Accepted pathological mechanisms and predisposing factors of hemorrhoids include reduced venous drainage, straining while defecating, constipation, pregnancy, portal hypertension and anorectal varices, and other risk factors.
Given the pathophysiological and accelerating factors described above, an increase in hemorrhoidal disease in modern society is to be expected. People today prefer a more sedentary lifestyle and partake of a low-fiber diet richer in high calorie/high fat foods compared with previous generations. In addition, smartphones have invaded nearly every aspect of daily life. Based on clinical observations, the investigators have found that the use of mobile phones in the lavatory has become a habit for some people. The investigators surmise that this habit, which increases the time spent on the toilet, also leads to an increase in pressure on the anal region and straining during defecation. There is a gap in the literature investigating the relationship between these two situations (smartphone use in the lavatory and the development of hemorrhoids), and researching this relationship could reveal important information. The basic research question of the present study is thus designed to determine to what extent the use of smartphones increases time spent in the lavatory and whether there is an association between this increase in time and hemorrhoidal disease.
This clinical study will be conducted with a cross-sectional design based on retrospective observation. Apart from the target population there will be a control group. In retrospective studies the selection of the control group is of the utmost importance. Other than the risk factor that is being investigated (the use of smartphones), factors that affect the development of hemorrhoid disease are similar for the study group and the control group, thus minimizing confounding factors. The control group, as will be noted, will thus have a social environment resembling that of the study group. It should also be noted that members of the control group will be completely healthy, with no health problems (e.g., hearing or visual disturbances) that could affect their use of the risk factor (smartphones).
The study population consists of patients with complaints of hemorrhoids referred to the General Surgery Polyclinic. The control group is comprised of healthy volunteers with no complaints of hemorrhoids. Both the study group and the control group will include persons of both genders between 16 and 65 years of age. Informed consent will be obtained from patients and volunteers, following which a Likert-type survey will be given to each participant to complete. A pilot study will be conducted for the factor analysis of the questions to be asked in the questionnaire. In the pilot study, the target will be to survey 100 patients. After the factor analysis is performed on 100 patients, the questionnaire that is developed will be used in the main study.
As no prevalence study was previously performed for the sample size, it will be calculated based on the prevalence (frequency of smartphone use in the lavatory in the study group and the control group) determined after the pilot study, by accepting a type I error of 0.05 and a type II error of 0.20 (80% test power).
The doctor who performs the examinations will be blinded to the questionnaire results. After completion of the questionnaire, the patient's anal region and rectum will be examined by a general surgeon and the presence or absence of hemorrhoids will be noted. Subsequently, if hemorrhoids are present, they will be recorded as either external or internal. Internal hemorrhoids will then be staged as first-degree, second-degree, third-degree, or fourth-degree, according to the standard textbook definitions.
- Conditions
- Hemorrhoids
- Medical subject headings
- Hemorrhoids
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 |
|---|---|---|
| Study group | Patients with hemorrhoids | |
| Control group | Healthy participants without hemorrhoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of hemorrhoids
A physical examination is performed by a general surgeon to determine presence or absence of hemorrhoids.
Measured: Through study completion (up to 7 months)
Secondary outcomes (2)
Degree of hemorrhoids (if present)
A physical examination is performed by a general surgeon to determine degree (1st to 4th) of hemorrhoids.
Measured: Through study completion (up to 7 months)
Smartphone usage habits in the lavatory
A questionnaire is used to investigate the relationship between smartphone use in the lavatory and hemorrhoid disease. The desired measure is the total amount of time (in minutes) that smartphone use in the lavatory increases time spent in the lavatory each day. This measure is based on the answers to two questions: the number of times per day that the participant uses the lavatory for defecation (1; 2; 3; 4; 5-10; more than 10), multiplied by the length of time that lavatory visits are increased due to smartphone use (no choices are given; instead, the participant enters the number of minutes).
Measured: Through study completion (up to 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Nov 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies 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
- 1,798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahattin Celik, Yuzuncu Yil University
- Investigators
- Sebahattin Celik, M.D., Principal investigator, Department of General Surgery, Yuzuncu Yil University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444389
- Sponsor's protocol ID
- 12/22/2017- 051
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haas PA, Haas GP, Schmaltz S, Fox TA Jr. The prevalence of hemorrhoids. Dis Colon Rectum. 1983 Jul;26(7):435-9. doi: 10.1007/BF02556521.
PubMed 6861574Fox A, Tietze PH, Ramakrishnan K. Anorectal conditions: hemorrhoids. FP Essent. 2014 Apr;419:11-9.
PubMed 24742083Gibbons CP, Bannister JJ, Read NW. Role of constipation and anal hypertonia in the pathogenesis of haemorrhoids. Br J Surg. 1988 Jul;75(7):656-60. doi: 10.1002/bjs.1800750712.
PubMed 3416121Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
PubMed 2295392Johanson JF, Sonnenberg A. Constipation is not a risk factor for hemorrhoids: a case-control study of potential etiological agents. Am J Gastroenterol. 1994 Nov;89(11):1981-6.
PubMed 7942722Wald A. Constipation, diarrhea, and symptomatic hemorrhoids during pregnancy. Gastroenterol Clin North Am. 2003 Mar;32(1):309-22, vii. doi: 10.1016/s0889-8553(02)00069-9.
PubMed 12635420Staroselsky A, Nava-Ocampo AA, Vohra S, Koren G. Hemorrhoids in pregnancy. Can Fam Physician. 2008 Feb;54(2):189-90.
PubMed 18272631Gojnic M, Dugalic V, Papic M, Vidakovic S, Milicevic S, Pervulov M. The significance of detailed examination of hemorrhoids during pregnancy. Clin Exp Obstet Gynecol. 2005;32(3):183-4.
PubMed 16433160Bernstein WC. What are hemorrhoids and what is their relationship to the portal venous system? Dis Colon Rectum. 1983 Dec;26(12):829-34. doi: 10.1007/BF02554764.
PubMed 6605842Misra SP, Dwivedi M, Misra V. Prevalence and factors influencing hemorrhoids, anorectal varices, and colopathy in patients with portal hypertension. Endoscopy. 1996 May;28(4):340-5. doi: 10.1055/s-2007-1005477.
PubMed 8813499Lowney JK, Fleshman JW Jr. Benign disorders of the anorectum (pelvic floor, fissures, hemorrhoids, and fistulas). In: Zinner MJ, Ashley SW, eds. Maingot's Abdominal Operations. 11th ed. New York: McGraw-Hill; 2007: 663-693.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory
- ClinicalTrials.gov ID
- NCT03444389
- Acronym / sponsor ID
- 12/22/2017- 051
- Conditions
- Hemorrhoids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,798 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 23 Feb 2018 (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.
The objective of this study is to examine the relationship between hemorrhoids, a common complaint, and the use of smartphones, also a common feature of modern life, in the lavatory.
As is known, hemorrhoidal disease is a frequently observed disease of the lower rectum and anal region that seriously impairs the patient's quality of life.
Based on clinical observations, the study investigators have found that the use of mobile phones in the lavatory has become a habit for some people. The investigators surmise that this habit, which increases the time spent on the toilet, also leads to an increase in pressure on the anal region and straining during defecation. There is a gap in the literature investigating the relationship between these two situations (smartphone use in the lavatory and the development of hemorrhoids). The basic research question of the present study is thus designed to determine to what extent the use of smartphones increases time spent in the lavatory and whether there is an association between this increase in time and hemorrhoidal disease.
Detailed description
The objective of this study is to examine the relationship between hemorrhoids, a common complaint, and the use of smartphones, also a common feature of modern life, in the lavatory.
As is known, hemorrhoidal disease is a frequently observed disease of the lower rectum and anal region that seriously impairs the patient's quality of life. The underlying pathophysiological event is vascular enlargement of the lower rectum. Hemorrhoids are classified as internal or external, and it is assumed that the same pathological mechanisms operate in both types. Accepted pathological mechanisms and predisposing factors of hemorrhoids include reduced venous drainage, straining while defecating, constipation, pregnancy, portal hypertension and anorectal varices, and other risk factors.
Given the pathophysiological and accelerating factors described above, an increase in hemorrhoidal disease in modern society is to be expected. People today prefer a more sedentary lifestyle and partake of a low-fiber diet richer in high calorie/high fat foods compared with previous generations. In addition, smartphones have invaded nearly every aspect of daily life. Based on clinical observations, the investigators have found that the use of mobile phones in the lavatory has become a habit for some people. The investigators surmise that this habit, which increases the time spent on the toilet, also leads to an increase in pressure on the anal region and straining during defecation. There is a gap in the literature investigating the relationship between these two situations (smartphone use in the lavatory and the development of hemorrhoids), and researching this relationship could reveal important information. The basic research question of the present study is thus designed to determine to what extent the use of smartphones increases time spent in the lavatory and whether there is an association between this increase in time and hemorrhoidal disease.
This clinical study will be conducted with a cross-sectional design based on retrospective observation. Apart from the target population there will be a control group. In retrospective studies the selection of the control group is of the utmost importance. Other than the risk factor that is being investigated (the use of smartphones), factors that affect the development of hemorrhoid disease are similar for the study group and the control group, thus minimizing confounding factors. The control group, as will be noted, will thus have a social environment resembling that of the study group. It should also be noted that members of the control group will be completely healthy, with no health problems (e.g., hearing or visual disturbances) that could affect their use of the risk factor (smartphones).
The study population consists of patients with complaints of hemorrhoids referred to the General Surgery Polyclinic. The control group is comprised of healthy volunteers with no complaints of hemorrhoids. Both the study group and the control group will include persons of both genders between 16 and 65 years of age. Informed consent will be obtained from patients and volunteers, following which a Likert-type survey will be given to each participant to complete. A pilot study will be conducted for the factor analysis of the questions to be asked in the questionnaire. In the pilot study, the target will be to survey 100 patients. After the factor analysis is performed on 100 patients, the questionnaire that is developed will be used in the main study.
As no prevalence study was previously performed for the sample size, it will be calculated based on the prevalence (frequency of smartphone use in the lavatory in the study group and the control group) determined after the pilot study, by accepting a type I error of 0.05 and a type II error of 0.20 (80% test power).
The doctor who performs the examinations will be blinded to the questionnaire results. After completion of the questionnaire, the patient's anal region and rectum will be examined by a general surgeon and the presence or absence of hemorrhoids will be noted. Subsequently, if hemorrhoids are present, they will be recorded as either external or internal. Internal hemorrhoids will then be staged as first-degree, second-degree, third-degree, or fourth-degree, according to the standard textbook definitions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with hemorrhoids |
| Control group | – | –Healthy participants without hemorrhoids |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.
Key inclusion criteria (3 listed)
- The study group consists of people with hemorrhoids.
- The control group consists of healthy participants without hemorrhoids.
- The study and control groups should have similar habits in terms of lifestyle, eating habits, etc.
Key exclusion criteria (2 listed)
- The control group participants should have no vision, hearing, or other problems that restrict or otherwise affect their use of smartphones (the risk factor).
- Participants should not have health problems that may be a causative factor in the pathogenesis of hemorrhoids.
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
Presence or absence of hemorrhoids
Time frame: Through study completion (up to 7 months)
A physical examination is performed by a general surgeon to determine presence or absence of hemorrhoids.
2 secondary outcomes
Degree of hemorrhoids (if present)
Time frame: Through study completion (up to 7 months)
Smartphone usage habits in the lavatory
Time frame: Through study completion (up to 7 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 6861574Haas PA, Haas GP, Schmaltz S, Fox TA Jr. The prevalence of hemorrhoids. Dis Colon Rectum. 1983 Jul;26(7):435-9. doi: 10.1007/BF02556521.
- Background: PubMed 24742083Fox A, Tietze PH, Ramakrishnan K. Anorectal conditions: hemorrhoids. FP Essent. 2014 Apr;419:11-9.
- Background: PubMed 3416121Gibbons CP, Bannister JJ, Read NW. Role of constipation and anal hypertonia in the pathogenesis of haemorrhoids. Br J Surg. 1988 Jul;75(7):656-60. doi: 10.1002/bjs.1800750712.
- Background: PubMed 2295392Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.
- Background: PubMed 7942722Johanson JF, Sonnenberg A. Constipation is not a risk factor for hemorrhoids: a case-control study of potential etiological agents. Am J Gastroenterol. 1994 Nov;89(11):1981-6.
- Background: PubMed 12635420Wald A. Constipation, diarrhea, and symptomatic hemorrhoids during pregnancy. Gastroenterol Clin North Am. 2003 Mar;32(1):309-22, vii. doi: 10.1016/s0889-8553(02)00069-9.
- Background: PubMed 18272631Staroselsky A, Nava-Ocampo AA, Vohra S, Koren G. Hemorrhoids in pregnancy. Can Fam Physician. 2008 Feb;54(2):189-90.
- Background: PubMed 16433160Gojnic M, Dugalic V, Papic M, Vidakovic S, Milicevic S, Pervulov M. The significance of detailed examination of hemorrhoids during pregnancy. Clin Exp Obstet Gynecol. 2005;32(3):183-4.
- Background: PubMed 6605842Bernstein WC. What are hemorrhoids and what is their relationship to the portal venous system? Dis Colon Rectum. 1983 Dec;26(12):829-34. doi: 10.1007/BF02554764.
- Background: PubMed 8813499Misra SP, Dwivedi M, Misra V. Prevalence and factors influencing hemorrhoids, anorectal varices, and colopathy in patients with portal hypertension. Endoscopy. 1996 May;28(4):340-5. doi: 10.1055/s-2007-1005477.
- BackgroundLowney JK, Fleshman JW Jr. Benign disorders of the anorectum (pelvic floor, fissures, hemorrhoids, and fistulas). In: Zinner MJ, Ashley SW, eds. Maingot's Abdominal Operations. 11th ed. New York: McGraw-Hill; 2007: 663-693.
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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.
Sebahattin Celik, M.D. principal investigator
Department of General Surgery, Yuzuncu Yil University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids, run by Yuzuncu Yil University at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebahattin Celik, M.D. (90 432 4445065 ext. 26099, scelik@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of hemorrhoids (time frame: Through study completion (up to 7 months)). 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 NCT03444389, which also lists 11 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 23 Feb 2018.