Published online Mar 28, 2015. doi: 10.3748/wjg.v21.i12.3593
Peer-review started: September 1, 2014
First decision: September 15, 2014
Revised: October 19, 2014
Accepted: January 8, 2015
Article in press: January 8, 2015
Published online: March 28, 2015
AIM: 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.
CONCLUSION: Modified formalin irrigation is an effective and safe method for hemorrhagic CRP, but should be performed cautiously in patients with a high endoscopic VRS.
Core tip: The study describes a modified topical formalin irrigation procedure that was well tolerated with long-term effectiveness for refractory hemorrhagic chronic radiation proctitis. The method focused on improving safety and reducing complications. The advantages of the procedure were as follows: protection of internal sphincter (spinal epidural anesthesia and the clasp-knife position provide full anal dilatation instead of dilatation by an anal retractor); protection of proximal normal colonic mucosa (Foley catheter inserted into the proximal sigmoid cavity to prevent damage from formalin backflow); targeting of the lesion area; and well-controlled volume and irrigation time.