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HemorrhoidNCT06878209

Cough and Hemorrhoids

An observational study of Hemorrhoid and Cough, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to investigate the relationship between hemorrhoids and cough by assessing the symptoms, duration, and severity of cough in patients who will present to the general surgery outpatient clinic of Muğla Education and Research Hospital (MERH) with symptoms such as bleeding, pain, itching, fecal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemorrhoid, Cough, Cough Duration
How many people
134 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Mar 2025to 14 Oct 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with hemorrhoidal disease in MERH General Surgery Outpatient Clinic who meet the inclusion criteria

Who may be able to join

  • Being 18 years of age or older
  • Speaking and understanding Turkish
  • To be mentally and cognitively capable of understanding the questions asked
  • To agree to participate in the research
  • individuals diagnosed with hemorrhoidal disease

Who cannot join

  • Those with existing proctologic disease other than hemorrhoidal disease and pelvic floor disease
  • Patients with previous surgery for hemorrhoidal disease
  • Patients with hemorrhoidal disease caused by portal hypertension
  • Patients during pregnancy and diagnosed with postpartum hemorrhoidal disease
  • those with benign prostatic hyperplasia or neurogenic bladder that may cause increased intra-abdominal pressure

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sabri Serhan Olcay contact

+905057578329

serhanolcay@mu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Muğla Training and Research Hospital

    Muğla, Menteşe, 48000

    Sabri Serhan Olcay, +905057578329, serhanolcay@mu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Is Cough a Predisposing Factor for Hemorrhoids? A Prospective, Analytical Study

The aim of the study is to investigate the relationship between hemorrhoids and cough by assessing the symptoms, duration, and severity of cough in patients who will present to the general surgery outpatient clinic of Muğla Education and Research Hospital (MERH) with symptoms such as bleeding, pain, itching, fecal leakage, prolapse, and mucus discharge. These patients will be diagnosed with hemorrhoidal disease through rectal examination to detect anal pathology and will be graded according to mucosal prolapse. Our study will aim to determine whether cough is a predisposing factor for hemorrhoids by evaluating the presence, duration, and frequency of cough symptoms in patients with hemorrhoids. The study will be designed as a cross-sectional, analytical, and descriptive study. Between March 2025 and June 2025, patients with newly diagnosed hemorrhoids who will present to the MEAH General Surgery Outpatient Clinic will undergo physical examinations and will be assessed for cough symptoms. Evaluations will include height and weight measurements, the Leicester Cough Questionnaire, the Cough Visual Analog Scale (VAS) questionnaire, duration of cough (categorized as acute if shorter than 4 weeks, or chronic if longer than 4 weeks), timing of cough (day, night, or all day), comorbidities (such as COPD, asthma, chronic bronchitis, interstitial lung disease, idiopathic pulmonary fibrosis, and others), and smoking history (active, former, or never smoked). The primary endpoint will be to compare the relationship between the severity of hemorrhoids and the duration and frequency of cough in patients with both conditions. The secondary endpoint will be to compare the grade of hemorrhoids with comorbid chest diseases in these patients. The tertiary endpoint will be to compare the degree of hemorrhoids with the smoking history of patients who have both hemorrhoids and cough.

Read the detailed description

Hemorrhoids are a collection of vascular tissue, smooth muscle, and connective tissue arranged in an inner column along the anal canal. Although they are normal structures, the term "hemorrhoids" refers to a pathological or symptomatic process. Internal hemorrhoids are located above the dentate line and are lined by columnar epithelium, which is innervated by visceral nerve fibers and not associated with pain, depending on the degree of prolapse, according to the Goligher classification. External hemorrhoids lie below the dentate line, are innervated by somatic nerves, and are usually asymptomatic.

Although the most common pathophysiologic cause of hemorrhoids is increased anal pressure at rest, the exact etiologic cause remains unclear. Factors that increase intra-abdominal pressure (IAP), such as straining during a bowel movement, prolonged sitting on the toilet, constipation/diarrhea, obesity, pregnancy, and age-related tissue weakening, can contribute to hemorrhoid development. However, the risk factors for hemorrhoids have not been sufficiently investigated.

The co-contraction of the thoracic, abdominal, and pelvic muscles results in a voluntary or reflex movement. This movement increases intrathoracic and intra-abdominal pressure (IAP), with IAP averaging 81.4-107.6 mmHg during coughing, compared to an average of 16.7 mmHg in the sitting position . The effect of coughing on IAP and its possible complications have been reported in case studies (e.g., urinary incontinence, pelvic organ prolapse) and electromyography studies.

  1. Sadiqa et al. reported that hemorrhoids may develop as a gastrointestinal complication of coughing, but the relationship between cough and hemorrhoids has never been prospectively investigated.

Although there are no studies on the prevalence of hemorrhoids in our country, it is the third most common gastrointestinal diagnosis in the USA, with approximately 4 million outpatient and emergency department visits per year. The epidemiology of hemorrhoids has been theorized but remains largely unsupported by reliable research. Simply put, the commonly believed risk factors for hemorrhoids have not been adequately investigated. From an epidemiologic standpoint, whether coughing is a predisposing factor for hemorrhoids will be investigated for the first time in our study. We believe that this study may provide valuable insights for determining goals and strategies for the treatment and management of hemorrhoids, optimizing resource utilization, and offering evidence-based recommendations to patients. The study will be conducted using a prospective observational data collection method. The sample size was calculated using G*Power 3 software (Institute of Experimental Psychology, Heinrich Heine University, Germany). Power analysis showed a medium effect size (Cohen's d: 0.5), and the minimum number of samples required to detect a statistical difference at 95% power and a significance level of α = 0.05 was 134.

Patients diagnosed with hemorrhoidal disease in the general surgery outpatient clinic of our hospital will be included in the study. Demographic information, such as age, gender, educational status, and occupational status, will be recorded for patients who sign the voluntary informed consent form. Additionally, data on the duration of hemorrhoidal disease based on symptomatology, the stage of the disease according to the Goligher classification, the presence of additional proctologic diseases, the presence or absence of constipation symptoms, the severity of bleeding, nutrition and toilet habits, and previous medical or surgical treatments for hemorrhoidal disease will be collected.

Information regarding the presence of cough, additional obstructive pulmonary diseases, medications, smoking or alcohol use, the Leicester Cough Questionnaire, and the Cough Visual Analog Scale (Cough VAS) will also be recorded. Patients with cough will be referred to the Department of Chest Diseases for diagnostic and therapeutic evaluation to investigate the etiology of cough.

If sufficient information is collected from a sufficient number of patients who meet the study criteria, the data will be analyzed.

Keywords
cough, hemorrhoid
Medical subject headings
Hemorrhoids, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06878209
Study groupRoleWhat they receive
coughing hemorrhoidsPatients diagnosed with hemorrhoidal disease in the general surgery outpatient clinic of our hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leicester cough questionnaire

    The primary endpoint is to compare the relationship between the severity of hemorrhoids and the duration and frequency of cough in patients with hemorrhoids and cough.

    Measured: day 1

Secondary outcomes (1)
  1. Comobidities

    The secondary endpoint was to compare the grade of hemorrhoids and comorbidities of chest diseases in patients with hemorrhoids and cough.

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start14 Mar 2025
  3. Primary completion14 Sep 2025 (estimated)
  4. Study completion14 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
134 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878209
Sponsor's protocol ID
35
Status last verified
Mar 2025
First submitted
10 Mar 2025
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhoid and Cough, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sabri Serhan Olcay (+905057578329, serhanolcay@mu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leicester cough questionnaire (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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