History of Changes for Study: NCT03444389

The Relationship Between Hemorrhoids and Smartphone Use in the Lavatory

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Version	A	B	Submitted Date	Changes
1			February 18, 2018	None (earliest Version on record)

Study Identification


Unique Protocol ID:	12/22/2017- 051
Brief Title:	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
Secondary IDs:

Study Status


Record Verification:	February 2018
Overall Status:	Unknown status [Previously: Recruiting]
Study Start:	November 1, 2017
Primary Completion:	June 1, 2018 [Anticipated]
Study Completion:	June 1, 2018 [Anticipated]

First Submitted:	January 31, 2018
First Submitted that Met QC Criteria:	February 18, 2018
First Posted:	February 23, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	February 18, 2018
Last Update Posted:	February 23, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	Yuzuncu Yıl University
Responsible Party:	Principal Investigator Investigator: Sebahattin Celik Official Title: Assistant Professor, Department of General Surgery Affiliation: Yuzuncu Yıl University
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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.

Conditions


Conditions:	Hemorrhoids
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Case-Control
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	1798 [Anticipated]
Number of Groups/Cohorts	2

Groups and Interventions

Groups/Cohorts	Interventions
Study group Patients with hemorrhoids
Control group Healthy participants without hemorrhoids

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	Degree of hemorrhoids (if present) [ Time Frame: Through study completion (up to 7 months) ] A physical examination is performed by a general surgeon to determine degree (1st to 4th) of hemorrhoids.
2.	Smartphone usage habits in the lavatory [ Time Frame: Through study completion (up to 7 months) ] 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).

Eligibility


Study Population:	Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.
Sampling Method:	Non-Probability Sample
Minimum Age:	16 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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.

Contacts/Locations


Study Officials:	Sebahattin Celik, M.D. Principal Investigator Department of General Surgery, Yuzuncu Yil University Faculty of Medicine
Locations:	Turkey
	Yuzuncu Yil University Faculty of Medicine Van, Turkey, 65080 Contact:Contact: Sebahattin Celik, M.D. 90 432 4445065 Ext. 26099 scelik@yyu.edu.tr

IPDSharing


Plan to Share IPD:

References


Citations:	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 6861574
	Fox A, Tietze PH, Ramakrishnan K. Anorectal conditions: hemorrhoids. FP Essent. 2014 Apr;419:11-9. PubMed 24742083
	Gibbons 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 3416121
	Johanson 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 2295392
	Johanson 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 7942722
	Wald 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 12635420
	Staroselsky A, Nava-Ocampo AA, Vohra S, Koren G. Hemorrhoids in pregnancy. Can Fam Physician. 2008 Feb;54(2):189-90. PubMed 18272631
	Gojnic 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 16433160
	Bernstein 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 6605842
	Misra 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 8813499
	Lowney 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.
Links:
Available IPD/Information:

Document Section


	Study Protocol Document Date: February 11, 2018 Uploaded: 02/18/2018 18:52 File Name: Prot_000.pdf
	Statistical Analysis Plan Document Date: February 11, 2018 Uploaded: 02/18/2018 18:53 File Name: SAP_001.pdf
	Informed Consent Form Document Date: December 22, 2017 Uploaded: 02/18/2018 18:53 File Name: ICF_002.pdf