Background: Chronic radiation proctitis with bleeding is a common problem encountered following radiotherapy for pelvic malignancy. Sucralfate-steroid enema and formalin dab are two common non-surgical intervention often used for this problem and are compared in this randomized trial.
Methods: This was a prospective randomized controlled trial conducted in JIPMER from August 2005 to May 2007. 102 patients with chronic radiation proctitis having bleeding per rectum following radiotherapy for carcinoma cervix were recruited and randomly allocated into 2 groups: group 1-formalin dab, group 2- sucralfate-steroid retention enema. Mean age of patients was 51.3±5.05 years. Mean time gap between end of radiotherapy and onset of bleeding per rectum was 12.37±3.53 months. Symptom score and sigmoidoscopic grade were assessed before treatment and one month after treatment in both the groups.
Results: 46/51(90.20%) patients in formalin group and 38/ 51(74.5%) patients in sucralfate group responded to treatment and the difference was statistically significant (p=0.038). On analysing symptom score and sigmoidoscopic grade before and after treatment within each group, there was a significant improvement in these scores in both formalin and sucralfate groups (p=0.000). In spite of having a higher median symptom score before treatment, patients in formalin group demonstrated a marked decrease in symptom score after treatment compared to patients in sucralfate group and the difference was statistically significant (p=0.000). Similarly the median sigmoidoscopic grade was significantly lower in formalin group compared to sucralfate group after treatment (p=0.000). The mean follow up period in the entire study group was 6.26±2.70 months. There were no specific treatment related complications in both groups.
Conclusions: 4% formalin dab is superior to sucralfate-steroid retention enema for treatment of chronic hemorrhagic radiation proctitis and should be used as the primary therapy for this condition. Formalin dab can be carried out as an outpatient procedure and has no significant side effects.