title: Formalin irrigation for hemorrhagic chronic radiation proctitis.
abstract: OBJECTIVE
  To assess the efficacy and safety of a modified topical formalin irrigation method in refractory hemorrhagic chronic radiation proctitis (CRP).
  
  
  METHODS
  Patients with CRP who did not respond to previous medical treatments and presented with grade II-III rectal bleeding according to the Common Terminology Criteria for Adverse Events were enrolled. Patients with anorectal strictures, deep ulcerations, and fistulas were excluded. All patients underwent flexible endoscopic evaluation before treatment. Patient demographics and clinical data, including primary tumor, radiotherapy and previous treatment options, were collected. Patients received topical 4% formalin irrigation in a clasp-knife position under spinal epidural anesthesia in the operating room. Remission of rectal bleeding and related complications were recorded. Defecation, remission of bleeding, and other symptoms were investigated at follow-up. Endoscopic findings in patients with rectovaginal fistulas were analyzed.
  
  
  RESULTS
  Twenty-four patients (19 female, 5 male) with a mean age of 61.5 ± 9.5 years were enrolled. The mean time from the end of radiotherapy to the onset of bleeding was 11.1 ± 9.0 mo (range: 2-24 mo). Six patients (25.0%) were blood transfusion dependent. The median preoperative Vienna Rectoscopy Score (VRS) was 3 points. Nineteen patients (79.2%) received only one course of topical formalin irrigation, and five (20.8%) required a second course. No side effects were observed. One month after treatment, bleeding cessation was complete in five patients and obvious in 14; the effectiveness rate was 79.1% (19/24). For long-term efficacy, 5/16, 1/9 and 0/6 patients complained of persistent bleeding at 1, 2 and 5 years after treatment, respectively. Three rectovaginal fistulas were found at 1 mo, 3 mo and 2 years after treatment. Univariate analysis showed associations of higher endoscopic VRS and ulceration score with risk of developing rectovaginal fistula.
  
  
  CONCLUSIONS
  Modified formalin irrigation is an effective and safe method for hemorrhagic CRP, but should be performed cautiously in patients with a high endoscopic VRS.
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Teng-Hui
authors.initials: TH
authors.lastname: Ma
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Zi-Xu
authors.initials: ZX
authors.lastname: Yuan
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Qing-Hua
authors.initials: QH
authors.lastname: Zhong
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Huai-Ming
authors.initials: HM
authors.lastname: Wang
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Qi-Yuan
authors.initials: QY
authors.lastname: Qin
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Xiao-Xia
authors.initials: XX
authors.lastname: Chen
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Jian-Ping
authors.initials: JP
authors.lastname: Wang
authors.affiliation: Teng-Hui Ma, Zi-Xu Yuan, Qing-Hua Zhong, Huai-Ming Wang, Qi-Yuan Qin, Xiao-Xia Chen, Jian-Ping Wang, Lei Wang, Department of Colorectal Surgery, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510655, Guangdong Province, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
mesh_terms: D000368:Aged; D002908:Chronic Disease; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005557:Formaldehyde / Q000008:administration & dosage* / Q000009:adverse effects; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011237:Predictive Value of Tests; D011349:Proctitis / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D012189:Retrospective Studies; D012307:Risk Factors; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005557:Formaldehyde
keywords: Chronic radiation proctitis; Efficacy; Rectal bleeding; Safety; Topical formalin irrigation
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