HemorrhoidNCT06878209
Cough and Hemorrhoids
An observational study of Hemorrhoid and Cough, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Muğla Training and Research Hospital
Muğla, Menteşe, 48000
Sabri Serhan Olcay, +905057578329, serhanolcay@mu.edu.tr
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.
- 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.
- Conditions
- Hemorrhoid, Cough, Cough Duration, Cough Frequency, Cough Severity, Hemorrhoids, Internal
- 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 group | Role | What they receive |
|---|---|---|
| coughing hemorrhoids | Patients 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.
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)
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.
- First posted14 Mar 2025
- Study start14 Mar 2025
- Primary completion14 Sep 2025 (estimated)
- Study completion14 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Serhan OLCAY, Muğla Sıtkı Koçman University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cough a Predisposing Factor for Hemorrhoids? A Prospective, Analytical Study
- ClinicalTrials.gov ID
- NCT06878209
- Acronym / sponsor ID
- 35
- Conditions
- Hemorrhoid, Cough, Cough Duration, Cough Frequency, Cough Severity, Hemorrhoids, Internal
- Keywords
- cough, hemorrhoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 14 Sep 2025 (estimated)
- Study completion
- 14 Oct 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coughing hemorrhoids | – | –Patients diagnosed with hemorrhoidal disease in the general surgery outpatient clinic of our hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hemorrhoidal disease in MERH General Surgery Outpatient Clinic who meet the inclusion criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leicester cough questionnaire
Time frame: day 1
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.
1 secondary outcome
Comobidities
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.