Clinical trial NCT03444389: The Relationship Between Hemorrhoids and Smartphone Use in the Lavatory
Official title: An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhoids
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 1798
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Presence or absence of hemorrhoids
timeFrame: Through study completion (up to 7 months)
Secondary outcomes:
measure: Degree of hemorrhoids (if present)
timeFrame: Through study completion (up to 7 months)
measure: Smartphone usage habits in the lavatory
timeFrame: Through study completion (up to 7 months)
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University Faculty of Medicine
Study officials:
affiliation: Department of General Surgery, Yuzuncu Yil University Faculty of Medicine
name: Sebahattin Celik, M.D.
role: PRINCIPAL_INVESTIGATOR
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