An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory
Conditions: Hemorrhoids
Sponsor: Yuzuncu Yil University

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AN INVESTIGATION INTO THE RELATIONSHIP BETWEEN HEMORRHOID 
DISEASE AND THE USE OF SMARTPHONES IN THE LAVATORY 
 
 
Unique Protocol ID: 12/22/2017 – 051 
Date: February 11, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY PROTOCOL 
 
The objective of medical research:  A changing world not only brings about different 
lifestyles and diverse eating habits, it also changes the causes and courses of known diseases. 
The goal 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. 
The scientific basis and validity of medical research: 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. Its worldwide prevalence is reported to be approximately 4.4% [1, 2]. 
One out of every two people over the age of 50 is reported to experience symptomatic 
hemorrhoidal disease, with increased frequency with age, especially after the age of 45 [3]. 
 
The underlying physiopathological event is vascular enlargement of the lower 
rectum [2]. Hemorrhoids are classified as internal or external, and it is assumed that the same 
pathological mechanisms operate in both types (Figure 1). Accepted pathological 
mechanisms and predisposing factors are summarized as follows: 
 
Reduced venous drainage 
Many researchers believe that foods low in fiber reduce stool caliber and cause an increase in 
straining during defecation, thereby increasing the pressure on the anal region [4]. The 
increased pressure in the anal region leads to prolapsed hemorrhoids and at the same time 
inhibits venous return. The inhibition of venous return further increases the prolapse of 
hemorrhoids thus rendering it symptomatic. Hemorrhoids may also develop via the 
aforementioned mechanism in situations where pressure is augmented such as pregnancy and 
increased anal sphincter tone. Sitting on the toilet for a long time (for example, while reading 
a newspaper) has been determined to inhibit venous drainage (the tourniquet effect) [5]. 
Together with aging, the weakening-loosening of the connective tissue supporting hemorrhoid 
papillae accelerates the development of hemorrhoidal disease. 
  
Straining and constipation  
Chronic constipation and straining have long been recognized as the primary cause of 
hemorrhoidal disease. Although there has been a number of studies that support this, data that 
do not support this conclusion have also been reported [4-6]. It is generally accepted that 

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increased pressure in the anal canal is greater in those with hemorrhoidal disease and that this 
pressure decreases following surgery. 
Pregnancy   
The effect of pregnancy on the development of hemorrhoids is evidenced by the postpartum 
disappearance of hemorrhoidal symptoms. Increased intra-abdominal pressure and hormonal 
changes experienced during pregnancy may cause hemorrhoids [7-9]. 
Portal hypertension and anorectal varices  
Although anorectal varices are often accompanied by portal hypertension, symptomatic 
hemorrhoids are not often observed in patients with portal hypertension [10, 11]. In cases of 
bleeding the varices should be sutured. Hemorrhoidal disease also regresses with the 
resolution of underlying liver problems. 
Other risk factors   
Other factors believed to be related to the development of hemorrhoids include the following: 
Higher socio-economic status, chronic diarrhea, family history, obesity, anal intercourse, 
hepatic diseases, inflammatory bowel diseases, rectal surgery, colon cancer, and spinal 
surgery. 
 
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. In clinical observations, the investigators have found that the use of 
mobile phones in the lavatory has become a habit for some people. This habit, which 
increases the time spent on the toilet, is also thought to lead to an increase in pressure on the 
anal region and straining during defecation. The investigators have not encountered any 
studies in the literature investigating the relationship between these two situations 
(smartphone use in the lavatory and the development of hemorrhoids). There is therefore a 
gap in the literature examining this relationship. Researching this relationship by means of the 
scientific method should 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. 

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Study protocol, methods, and procedures: 
This clinical study will be conducted with a cross-sectional design based on 
retrospective observation (Figure 2). 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 hemorrhoidal 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 (Figure 3). 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 (Table 1, questionnaire form). 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, accepting a type I error of 0.005 
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 standard textbook definitions [2]. 
Primary endpoints of the study: 
1) determination of the stage of hemorrhoids in patients with complaints of hemorrhoids 

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2) frequency and duration of smartphone use in the lavatory for those with smartphones 
 
Statistical Data Analysis:  
All data will be analyzed using the SPSS version 20 package program. The data will consist 
of categorical nominal and continuous numerical variables. Frequency and percentages will 
be given for categorical and nominal variables. Following testing for normal distribution of 
numerical variables, those with normal distribution will be expressed as mean ± standard 
deviation, while variables without normal distribution will be expressed as median value and 
minimum - maximum. The relationship between the risk factor and the outcome variable will 
be assessed using the Chi-square test. The difference between hemorrhoid stages in terms of 
exposure times to the risk factor will be determined by ANOVA or the Kruskal-Wallis test. A 
p value of 0.05 will be accepted as statistically significant. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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