| NCT ID | NCT06878209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Muğla Sıtkı Koçman University |
| Condition | Hemorrhoid |
| Study Type | OBSERVATIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2025-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 134 participants in total. It began in 2025-03-14 with a primary completion date of 2025-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Being 18 years of age or older 2. Speaking and understanding Turkish 3. To be mentally and cognitively capable of understanding the questions asked 4. To agree to participate in the research 5. individuals diagnosed with hemorrhoidal disease Exclusion Criteria: 1. Those with existing proctologic disease other than hemorrhoidal disease and pelvic floor disease 2. Patients with previous surgery for hemorrhoidal disease 3. Patients with hemorrhoidal disease caused by portal hypertension 4. Patients during pregnancy and diagnosed with postpartum hemorrhoidal disease 5. those with benign prostatic hyperplasia or neurogenic bladder that may cause increased intra-abdominal pressure
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06878209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemorrhoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06878209 currently recruiting?
Yes, NCT06878209 is actively recruiting participants. Contact the research team at serhanolcay@mu.edu.tr for enrollment information.
Where is the NCT06878209 trial being conducted?
This trial is being conducted at Muğla, Turkey (Türkiye).
Who is sponsoring the NCT06878209 clinical trial?
NCT06878209 is sponsored by Muğla Sıtkı Koçman University. The trial plans to enroll 134 participants.