NCT06878209

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

May 11, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 10, 2025

Last Update Submit

May 8, 2025

Conditions

Keywords

cough, hemorrhoid

Outcome Measures

Primary Outcomes (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.

    day 1

Secondary Outcomes (1)

  • Comobidities

    day 1

Other Outcomes (1)

  • Smoking

    day 1

Study Arms (1)

coughing hemorrhoids

Patients diagnosed with hemorrhoidal disease in the general surgery outpatient clinic of our hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HemorrhoidsCough

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sabri Serhan Olcay

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

March 14, 2025

Primary Completion

September 14, 2025

Study Completion

October 14, 2025

Last Updated

May 11, 2025

Record last verified: 2025-03

Locations