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Vessel-sparing Excision and Primary Anastomosis
Published on: January 7, 2019
Effectiveness of a Natural-Rubber Anal Dilator (ParaSelf) After Pediatric Anorectal Surgery: A Historical-Controlled
Kwanhathai Sakulsansern1, Suppachai Lawanaskol2
1Department of Surgery, Sawanpracharak Hospital, Nakhon Sawan, Thailand.
Insights
ParaSelf, a natural rubber anal dilator, significantly speeds up anal dilation and reduces pain in children post-anorectal surgery compared to rigid dilators. Caregiver satisfaction is higher, with no reported complications.
Area of Science:
- Pediatric Surgery
- Gastroenterology
- Medical Device Innovation
Background:
- Anal stenosis is a common complication following anorectal reconstruction for conditions like anorectal malformation (ARM) and Hirschsprung disease (HD).
- Conventional rigid dilators present challenges in pediatric use due to discomfort, cost, and poor anatomical fit.
- Natural rubber dilators offer potential advantages in conformity and patient outcomes but require evaluation.
Purpose of the Study:
- To compare the efficacy and safety of ParaSelf, a novel natural rubber dilator, against conventional rigid dilators.
- To assess ParaSelf's impact on achieving target anal diameter, pain levels, and caregiver satisfaction in pediatric patients.
Main Methods:
- A retrospective cohort study involving 98 children with ARM or HD.
- Comparison between a pre-implementation cohort using conventional dilators (2017-2022) and a post-implementation cohort using ParaSelf (2022-2025).
- Primary endpoint: time to achieve age-specific target anal diameter; secondary endpoints: anal stenosis, pain, caregiver satisfaction, and complications.
Main Results:
- The ParaSelf group achieved the target anal diameter significantly faster (median 5.6 months) than the control group (median 9.4 months).
- ParaSelf demonstrated a nearly 10-fold higher hazard of reaching the target diameter (HR = 9.9, P < 0.001).
- Lower pain scores (median difference = -2.58) and higher caregiver satisfaction (median difference = 2.00) were observed with ParaSelf; no surgery-requiring stenosis or irritation occurred.
Conclusions:
- ParaSelf offers a more effective and acceptable alternative to conventional dilators for pediatric anorectal reconstruction.
- The natural rubber dilator is associated with faster treatment, reduced pain, and improved patient/caregiver experience.
- ParaSelf shows promise in mitigating anal stenosis complications and enhancing post-surgical care in pediatric ARM and HD patients.
Background:
Anal stenosis is a frequent complication after anorectal reconstruction for anorectal malformation (ARM) or Hirschsprung disease (HD). Conventional rigid dilators are uncomfortable, expensive, and poorly adapted to pediatric anatomy. Natural rubber dilators may offer better conformity and outcomes but have not been evaluated. The aim of the study was to compare the efficacy and safety of ParaSelf, a natural rubber-based anal dilator, with conventional rigid dilators in children after anorectal surgery.
Methods:
This retrospective cohort study included 98 children with ARMs or HD. Children who used conventional dilators during 2017-2022 served as the preimplementation control cohort, and children who used ParaSelf during 2022-2025 comprised the post-implementation cohort. The primary endpoint was time to achieve the age-specific target anal diameter, analyzed using multivariable Weibull parametric proportional hazards regression. Secondary endpoints included anal stenosis (including surgery-requiring stenosis), pain, caregiver satisfaction, and major postoperative complications.
Results:
Of 98 patients, 33 (33.7%) received ParaSelf. The ParaSelf group reached the target diameter faster than controls (median 5.6 vs. 9.4 months). Weibull regression showed a nearly 10-fold higher hazard of reaching the target diameter with ParaSelf (hazard ratio (HR) = 9.9; 95% confidence interval (CI), 5.2 to 18.7; P < 0.001). Pain scores during home dilation were lower (median difference = -2.58; 95% CI, -3.40 to -1.76; P < 0.001), and caregiver satisfaction was higher (median difference = 2.00; 95% CI, 1.52 to 2.48; P < 0.001) with ParaSelf versus conventional dilators. No irritation, bleeding, leakage, or surgery-requiring stenosis occurred in the ParaSelf group.
Conclusions:
ParaSelf was associated with faster dilation, less pain, fewer complications, and higher caregiver satisfaction than conventional dilators and may be a more acceptable alternative for pediatric anorectal reconstruction.
