Effective Treatments for Chronic Rectal Bleeding: A Study on Formalin vs. Argon Plasma Coagulatio
Phase 2
- Conditions
- Health Condition 1: K627- Radiation proctitis
- Registration Number
- CTRI/2024/08/071766
- Lead Sponsor
- Indira Gandhi Medical College Shimla Himachal Pradesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adults aged nore than 18 - 85 years .
2. History of radiation therapy for pelvic malignancies, conducted at least six months prior with history of intractable rectal bleeding ( defined as rectal bleeding of = 1 times per week or any bleeding requiring blood transfusion or intravenous iron supplementation)
Exclusion Criteria
1. Expected survival of less than two years, as assessed by a radiation oncologist.
2. Detection of other potential sources of gastrointestinal bleeding via colonoscopy.
3. Patients with any history of endoscopic treatment for radiation proctopathy (Either APC or formalin)
4. Patients with anorectal stenosis, ulceration and fistula
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of APC vs formalin in patients of chronic radiation proctopathy in terms of intractable rectal bleeding.Timepoint: 4 weeks, 8 weeks, 12 weeks and 18 weeks
- Secondary Outcome Measures
Name Time Method To compare the efficacy of APC vs formalin in patients of chronic radiation proctopathy in terms of symptoms, anaemia, endoscopic improvement & adverse events. <br/ ><br> <br/ ><br>Timepoint: 4 weeks, 8 weeks, 12 weeks & 18 weeks