Health Condition 1: K641- Second degree hemorrhoids Health Condition 2: K642- Third degree hemorrhoids
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Adult patients aged 18 to 70 years 2. Grade II and III internal haemorrhoids
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Circumferential haemorrhoids or haemorrhoids in all 3, 7 and 11 o clock positions 2. Patients on anticoagulant and antiplatelet agents 3. Patients developing haemorrhoids secondary to portal hypertension 4. Patients who have undergone previous procedure for haemorrhoids 5. Presence of other associated perianal pathology including anal stenosis, anal fissure, fistula or anorectal tumors. 6. Patients on opioids or any substance abuse 7. Immunocompromised patients - Known HIV/ AIDS, patients on immunosuppressive drugs including steroids 8. Previous surgical anastomosis less than 3 cm from dentate line 9. Patients with inflammatory bowel disease 10. Fecal incontinence 11. Obstructed defecation syndrome 12. Irritable bowel syndrome with severe constipation or diarrhoea symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of symptoms (rectal bleeding, discomfort, itching, mucous discharge), determined by direct or telephonic interview of patients at three months after RBL or LH Timepoint: 24 hours, 1 week, 2 weeks, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of pain at 24 hours, 1 week, 2 weeks and 3 months, measured by Numerical Pain Rating Scale, on a scale of 0 to 10, where 0 is no pain and 10 is maximum possible pain 2. Procedure time, measured in minutes 3. Incidence of post procedure complications - Oedema, abscess, urinary retention, anal ulcer, acute thrombosis, unplanned hospital visits, hospital admissions at 30 days 4. Incidence of downgrading rates of hemorrhoidal disease by 1 grade or more, determined by direct examination by a trained surgeon during 3-montyh follow up visit. Timepoint: 24 hours, 1 week, 2 weeks, 3 months | — |
Countries
India
Contacts
AIIMS New Delhi