NCT03444389

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,798

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

January 31, 2018

Last Update Submit

February 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of hemorrhoids

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

    Through study completion (up to 7 months)

Secondary Outcomes (2)

  • Degree of hemorrhoids (if present)

    Through study completion (up to 7 months)

  • Smartphone usage habits in the lavatory

    Through study completion (up to 7 months)

Study Arms (2)

Study group

Patients with hemorrhoids

Control group

Healthy participants without hemorrhoids

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with complaints of hemorrhoids who were referred to the General Surgery Polyclinic.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University Faculty of Medicine

Van, 65080, Turkey (Türkiye)

RECRUITING

Related Publications (11)

  • 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.

    PMID: 6861574BACKGROUND
  • Fox A, Tietze PH, Ramakrishnan K. Anorectal conditions: hemorrhoids. FP Essent. 2014 Apr;419:11-9.

    PMID: 24742083BACKGROUND
  • 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.

    PMID: 3416121BACKGROUND
  • 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.

    PMID: 2295392BACKGROUND
  • 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.

    PMID: 7942722BACKGROUND
  • 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.

    PMID: 12635420BACKGROUND
  • Staroselsky A, Nava-Ocampo AA, Vohra S, Koren G. Hemorrhoids in pregnancy. Can Fam Physician. 2008 Feb;54(2):189-90.

    PMID: 18272631BACKGROUND
  • 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.

    PMID: 16433160BACKGROUND
  • 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.

    PMID: 6605842BACKGROUND
  • 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.

    PMID: 8813499BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sebahattin Celik, M.D.

    Department of General Surgery, Yuzuncu Yil University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebahattin Celik, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of General Surgery

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 23, 2018

Study Start

November 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations