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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie formalin's efficacy in treating haemorrhagic radiation proctitis compared to sucralfate-steroid enemas?
How does formalin dab compare to standard-of-care treatments for radiation-induced rectal bleeding in gynecological cancer patients?
Are there specific biomarkers that predict response to formalin therapy versus sucralfate-steroid enemas in post-radiotherapy rectal injury?
What are the known adverse events associated with formalin dab treatment for radiation proctitis and how are they managed?
What combination therapies or alternative compounds show promise in treating haemorrhagic radiation proctitis alongside or instead of formalin or sucralfate-steroid enemas?