AIM: Chronic radiation proctitis with bleeding is a common problem encountered following radiotherapy for pelvic malignancy. Sucralfate-steroid enema and formalin dab are two common nonsurgical treatments. A randomized trial was conducted to compare the efficacy of these two methods. METHOD: This was a prospective randomized controlled trial conducted in the Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) from August 2005 to May 2007. One-hundred and two patients with chronic radiation proctitis, presenting as rectal bleeding after radiotherapy for carcinoma of the cervix, were recruited and randomly allocated into two treatment groups: Group 1, formalin dab; and Group 2, sucralfate-steroid retention enema. The mean age of the patients was 51.3 ± 5.1 years. The mean interval between the end of radiotherapy and the onset of bleeding was 12.3 ± 3.5 months. Symptom score and sigmoidoscopic grade were assessed before, and at 1 month after, treatment. RESULTS: Ninety per cent of patients in Group 1 and 74.5% of patients in Group 2 responded to treatment (P = 0.038). In spite of having a higher median symptom score before treatment, patients in Group 1 demonstrated a marked decrease in symptom score after treatment compared with patients in Group 2 and the difference once again was statistically significant (P = 0.000). Similarly, the median sigmoidoscopic grade was significantly lower for patients in Group 1 compared with patients in Group 2 after treatment (P = 0.000). There were no specific treatment-related complications in either group. CONCLUSIONS:Formalin (4%) dab is superior to sucralfate-steroid retention enema for treatment of chronic haemorrhagic radiation proctitis.
RCT Entities:
AIM: Chronic radiation proctitis with bleeding is a common problem encountered following radiotherapy for pelvic malignancy. Sucralfate-steroid enema and formalin dab are two common nonsurgical treatments. A randomized trial was conducted to compare the efficacy of these two methods. METHOD: This was a prospective randomized controlled trial conducted in the Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) from August 2005 to May 2007. One-hundred and two patients with chronic radiation proctitis, presenting as rectal bleeding after radiotherapy for carcinoma of the cervix, were recruited and randomly allocated into two treatment groups: Group 1, formalin dab; and Group 2, sucralfate-steroidretention enema. The mean age of the patients was 51.3 ± 5.1 years. The mean interval between the end of radiotherapy and the onset of bleeding was 12.3 ± 3.5 months. Symptom score and sigmoidoscopic grade were assessed before, and at 1 month after, treatment. RESULTS: Ninety per cent of patients in Group 1 and 74.5% of patients in Group 2 responded to treatment (P = 0.038). In spite of having a higher median symptom score before treatment, patients in Group 1 demonstrated a marked decrease in symptom score after treatment compared with patients in Group 2 and the difference once again was statistically significant (P = 0.000). Similarly, the median sigmoidoscopic grade was significantly lower for patients in Group 1 compared with patients in Group 2 after treatment (P = 0.000). There were no specific treatment-related complications in either group. CONCLUSIONS:Formalin (4%) dab is superior to sucralfate-steroidretention enema for treatment of chronic haemorrhagic radiation proctitis.
Authors: Fleur T van de Wetering; Leen Verleye; H Jervoise N Andreyev; Jane Maher; Joan Vlayen; Bradley R Pieters; Geertjan van Tienhoven; Rob J P M Scholten Journal: Cochrane Database Syst Rev Date: 2016-04-25
Authors: Ben G L Vanneste; Lien Van De Voorde; Rogier J de Ridder; Evert J Van Limbergen; Philippe Lambin; Emile N van Lin Journal: Int J Colorectal Dis Date: 2015-07-23 Impact factor: 2.571