Effective Treatments for Chronic Rectal Bleeding: A Study on Formalin vs. Argon Plasma Coagulation

Comparison of efficacy of four percent formalin rectal application and argon plasma coagulation in patients of chronic radiation proctopathy with intractable rectal bleeding– An open label Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071766

Enrollment

Registered

2024-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K627- Radiation proctitis

Interventions

Intervention1: Argon plasma Coagulation: APC is a non-contact thermal electrocoagulation technique that uses high frequency monopolar current delivered via ionized argon gas to target tissues. . The p

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To compare the efficacy of APC vs formalin in patients of chronic radiation proctopathy in terms of symptoms, anaemia, endoscopic improvement & adverse events. Timepoint: 4 weeks, 8 weeks, 12 weeks & 18 weeks	—

Countries

India

Contacts

Public ContactBrij Sharma

Indira Gandhi Medical College Shimla

drbrijsharma01@gmail.com8194940088

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026