Health Condition 1: K649- Unspecified hemorrhoids
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged 1 8 years and older. 2. Indication for Proctoscopy: Patients with anorectal symptoms such as rectal bleeding, pain, itching, prolapse, o r other conditions requiring proctoscopy. 4. Consent: Patients who provide informed written consent to participate i n the study. 5. General Health: Patients who are medically fit to undergo a proctoscopy procedure. 6. Accessibility: Patients available for follow-up a s per study protocol.
Exclusion criteria
Exclusion criteria: 1. Severe Comorbidities: Patients with significant comorbid conditions (e.g., advanced cardiac, pulmonary, o r neurological diseases) that may increase procedural risk. 2 . Pregnancy: Pregnant individuals to avoid any potential risks associated with the procedure. 3. Previous Rectal Surgery: History of significant anorectal or rectal surgery that might alter anatomy or outcomes. 4 . Infections: Patients with active perianal o r rectal infections, including abscesses. 5 . Fissures or Severe Pain: Cases where severe anal fissures or intense pain may contraindicate the procedure. 6 . Uncooperative Behavior: Patients with conditions impairing cooperation, such as severe anxiety o r cognitive impairment. 7 . Contraindications for Proctoscopy: Any other condition deemed unsuitable for proctoscopy a t the discretion of the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of visualization of the anal canal and rectum Assessment of clarity, field of view, illumination, and lesion visibility achieved using the Proctoscope, as rated by the operating surgeon using a predefined grading scale. Timepoint: baseline . | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Diagnostic adequacy .Ability to identify anorectal pathology (e.g., fissure, hemorrhoids, fistula opening, mass, inflammation) 2.Ease of use (Operator-reported) Rated using a scale assessing overall usability of the device 3.Patient discomfort 4.Procedure duration Time taken to complete proctoscopic examination (in minutes) 5.Need for repeat examination .Requirement for repeat proctoscopy or alternate diagnostic modality due to inadequate visualization Timepoint: baseline | — |
Countries
India
Contacts
Saveetha Medical College and Hospital