Skip to content

A clinical trial comparing two conservative methods, formalin dab and sucralfate-steroid enema in treating patients with Inflamed rectum with bleeding due to radiation .

Efficacy of Formalin dab as a primary therapy for haemorrhagic radiation proctitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/12/002184
Enrollment
100
Registered
2011-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with carcinoma cervix who have been treated with radiotherapy

Interventions

Intervention1: 4% Formalin dab: Under local anaesthesia, areas of haemorrhagic radiation proctitis were dabbed with 4% formalin soaks through a sigmoidoscope for one or two minutes till the area gets

Sponsors

Jawaharlal Institute of PostGraduate Medical Education ResearchJIPMER
Lead Sponsor
Kadambari D
Collaborator
Reddy KS
Collaborator
Tarun Dilip Javali
Collaborator
Vishnu Prasad N R
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adult female patients who developed haemorrhagic radiation proctitis following radiotherapy for carcinoma cervix

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactTarun Dilip Javali

JIPMER

vprasad285@gmail.com9442233487

Outcome results

None listed

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