A clinical trial comparing two conservative methods, formalin dab and sucralfate-steroid enema in treating patients with Inflamed rectum with bleeding due to radiation .
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Patients with carcinoma cervix who have been treated with radiotherapy
- Registration Number
- CTRI/2011/12/002184
- Lead Sponsor
- Jawaharlal Institute of PostGraduate Medical Education ResearchJIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Adult female patients who developed haemorrhagic radiation proctitis following radiotherapy for carcinoma cervix
Exclusion Criteria
Residual malignancy, Ano-rectal fistula, stricture/stenosis, painful perianal condition, haemorrhoids, fissure-in-ano, lesions extending beyond the reach of sigmoidoscope( >25 cm), already received medical/surgical therapy for haemorrhagic radiation proctitis, bleeding diathesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiation proctopathy system assessment scale score to assess the symptoms before and after treatment and between groups. Assessment of Sigmoidoscopic grading of radiation proctopathy severity before and after treatment and between groups.Timepoint: One month after intervention
- Secondary Outcome Measures
Name Time Method Radiation proctopathy system assessment scale score to assess the symptoms before and after treatment after repeated formalin dabbing to see for no-response or relapse.Timepoint: One month after intervention or when symptoms worsened.