Ann Surg Treat Res.  2022 Dec;103(6):360-371. 10.4174/astr.2022.103.6.360.

Analgesic effect of structured anal skin care for perianal dermatitis after low anterior resection in the rectal cancer patients: prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial

Affiliations
  • 1Department of Surgery, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea
  • 2Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 3Division of Biostatistics, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 4Wound Ostomy Continence Nursing Center, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 5Department of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 6Department of Food Service and Clinical Nutrition, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 7Department of Food and Nutrition, College of Medical and Life Science, Silla University, Busan, Korea
  • 8Department of Acupuncture and Moxibustion, Pusan National University Korean Medicine Hospital, Yangsan, Korea

Abstract

Purpose
This prospective, single-center, open-label, therapeutic confirmatory, randomized clinical trial aimed to assess the alleviation of anal pain by applying structured anal skin care including skin protectants in rectal cancer patients with low anterior resection syndrome (LARS) combined with anal pain.
Methods
From December 2017 to May 2020, 42 patients with LARS (scores of ≥21) and anal pain (visual analogue scale [VAS] score of ≥3) were randomly assigned and observed for 4 weeks. The conventional treatment consisted of dietary management, sitz baths, prohibition of anal scrubbing, loperamide, and dioctahedral smectite. In the anal care group, cleanser, barrier cream, and barrier spray were applied to the anal skin after defecation following the conventional treatment. The primary outcome was analgesic effect on anal pain after 2 weeks of structured treatment (anal care group) or conventional (control group). The cutoff for analgesic effect was a decrease in the anal pain score (VAS score of ≥2 or ≥30% reduction).
Results
As a primary outcome, the analgesic effect was significantly higher in the anal care group (P = 0.034). The incontinence-associated dermatitis skin condition score was significantly improved in the anal care group than control group after 4 weeks (P = 0.023). There were no significant differences in LARS scores and quality of life scores between 2 groups.
Conclusion
Structured anal skin care has a significant analgesic effect in reducing anal pain and improving anal skin conditions in patients with LARS after rectal cancer surgery.

Keyword

Fecal incontinence; Irritant dermatitis; Pain management; Rectal neoplasms; Skin care

Figure

  • Fig. 1 Diagram for clinical trial.

  • Fig. 2 The anal pain and skin condition changes for 4 weeks of anal care treatment. (A) The anal pain scores using the pain visual analog scale in the anal care group (solid line) and control group (dotted line). (B) Skin dermatitis score using incontinence-associated dermatitis (IAD) skin condition assessment tool designed by Kenney and Lutz [13]. Repeated measures analysis of variance shows that the interaction between group and time was statistically significant for anal pain score (P = 0.002) and IAD score (P = 0.010). Time, P-value over treatment time course; Group, P-value comparing between anal care and control groups; Time × group, P-value of interactions between treatment time and patient groups. *P < 0.05.

  • Fig. 3 The correlation between patient’s anal pain score and low anterior resection syndrome (LARS) score at each visit points. Significant correlations were observed between the anal pain score and LARS score (r = 0.41, P = 0.008) in visit 1 (baseline). But these correlations became insignificant after structured or conventional anal care.

  • Fig. 4 The quality of life (QoL) assessment in the anal care and control groups using EORTC QLQ C-30 score. The mean value of each QoL score was indicated in the anal care group (solid line) and control group (dotted line). Repeated measures analysis of variance was used for analysis of the interaction between treatment time and patient groups. EORTC QLQ, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Time, P-value over treatment time course; Group, P-value comparing between anal care and control groups; Time × group, P-value of interactions between treatment time and patient groups. *P < 0.05


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