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临床试验/NCT03444389
NCT03444389Unknown不适用

An Investigation Into the Relationship Between Hemorrhoid Disease and the Use of Smartphones in the Lavatory

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 1,798 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,798
试验地点
1
主要终点
Presence or absence of hemorrhoids

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Presence or absence of hemorrhoids

时间窗: Through study completion (up to 7 months)

A physical examination is performed by a general surgeon to determine presence or absence of hemorrhoids.

次要结局

  • Smartphone usage habits in the lavatory(Through study completion (up to 7 months))
  • Degree of hemorrhoids (if present)(Through study completion (up to 7 months))

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebahattin Celik

Assistant Professor, Department of General Surgery

Yuzuncu Yıl University

研究点 (1)

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