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The Relationship Between Hemorrhoids and Smartphone Use in the Lavatory

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ClinicalTrials.gov Identifier: NCT03444389
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sebahattin Celik, Yuzuncu Yıl University

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.


Condition or disease
Hemorrhoids

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1798 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Group/Cohort
Study group
Patients with hemorrhoids
Control group
Healthy participants without hemorrhoids



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).



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444389


Contacts
Contact: Sebahattin Celik, M.D. 90 432 4445065 ext 26099 scelik@yyu.edu.tr

Locations
Turkey
Yuzuncu Yil University Faculty of Medicine Recruiting
Van, Turkey, 65080
Contact: Sebahattin Celik, M.D.    90 432 4445065 ext 26099    scelik@yyu.edu.tr   
Sponsors and Collaborators
Yuzuncu Yıl University
Investigators
Principal Investigator: Sebahattin Celik, M.D. Department of General Surgery, Yuzuncu Yil University Faculty of Medicine
  Study Documents (Full-Text)

Documents provided by Sebahattin Celik, Yuzuncu Yıl University:
Study Protocol  [PDF] February 11, 2018
Statistical Analysis Plan  [PDF] February 11, 2018
Informed Consent Form  [PDF] December 22, 2017


Publications:
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.

Responsible Party: Sebahattin Celik, Assistant Professor, Department of General Surgery, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03444389     History of Changes
Other Study ID Numbers: 12/22/2017- 051
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases