title: A randomized controlled trial comparing colonic irrigation and oral antibiotics administration versus 4% formalin application for treatment of hemorrhagic radiation proctitis.
abstract: BACKGROUND
  Several treatments have been described for hemorrhagic radiation proctitis. The treatment outcomes are variable. Colonic irrigation and oral antibiotics for hemorrhagic radiation proctitis have been recently reported to be a novel and promising therapeutic approach. However, a comparative study of this treatment has never been investigated.
  
  
  OBJECTIVE
  This study aimed to compare colonic irrigation and oral antibiotics (irrigation group) versus 4% formalin application (formalin group) for treatment of hemorrhagic radiation proctitis.
  
  
  METHODS
  This was a randomized controlled trial.
  
  
  METHODS
  This study was conducted in a tertiary care/university-based hospital.
  
  
  METHODS
  Fifty patients with hemorrhagic radiation proctitis were randomly assigned to each treatment group (n = 25).
  
  
  METHODS
  For individuals allocated to the irrigation group, daily self-administered colonic irrigation with 1 L of tap water and a 1-week period of oral antibiotics (ciprofloxacin and metronidazole) were prescribed. For individuals allocated to the formalin group, 4% formalin application for 3 minutes was performed.
  
  
  METHODS
  Patients' symptoms and the endoscopic findings of each group were collected. Patient satisfaction was surveyed. The outcomes were evaluated at 8 weeks after the initiation of treatment.
  
  
  RESULTS
  There was a significant improvement in rectal bleeding and bowel frequency in both treatment groups, but significant improvement in urgency, diarrhea, and tenesmus was demonstrated only in the irrigation group. The comparative study between 2 treatments revealed greater improvement in rectal bleeding, urgency, and diarrhea in the irrigation group. Twenty of 24 patients in the irrigation group and 10 of 23 patients in the formalin group were satisfied with the treatment.
  
  
  CONCLUSIONS
  This trial cannot illustrate whether the antibiotics and the irrigation were equally important because of the limitation of a 2-armed design.
  
  
  CONCLUSIONS
  The treatment with colonic irrigation and oral antibiotics appears to be more effective than 4% formalin application for hemorrhagic radiation proctitis treatment and achieves higher patient satisfaction.
authors.affiliation: Colorectal Division, Department of Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. chucheep@hotmail.com
authors.forename: Chucheep
authors.initials: C
authors.lastname: Sahakitrungruang
authors.forename: Attaporn
authors.initials: A
authors.lastname: Patiwongpaisarn
authors.forename: Prapon
authors.initials: P
authors.lastname: Kanjanasilp
authors.forename: Songphol
authors.initials: S
authors.lastname: Malakorn
authors.forename: Puttarat
authors.initials: P
authors.lastname: Atittharnsakul
mesh_terms: D000284:Administration, Oral; D000285:Administration, Rectal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002939:Ciprofloxacin / Q000008:administration & dosage*; D005260:Female; D005557:Formaldehyde / Q000008:administration & dosage*; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000628:therapy*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D011349:Proctitis / Q000209:etiology / Q000628:therapy*; D011351:Proctoscopy; D011832:Radiation Injuries / Q000150:complications / Q000628:therapy*; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D007507:Therapeutic Irrigation / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole; D005557:Formaldehyde; D002939:Ciprofloxacin