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Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial.

ABSTRACT:

Background

This prospective randomized controlled study was designed to evaluate the effect of biofeedback therapy (BFT) during temporary stoma period to prevent defecation dysfunction after sphincter-preserving surgery (SPS).

Methods

Following SPS with temporary stoma, patients were divided according to whether (BFT group) or not (Control group) they received BFT. BFT was performed once or twice a week during the temporary stoma period. Kegel exercise were advised to all the patients. Subjective defecation symptoms were evaluated according to Cleveland Clinic Incontinence Score (CCIS) as primary outcome at 12 months postoperatively. Manometric data of five time-points were also analyzed.

Results

Twenty-one patients in the BFT group and 23 patients in the control group received anorectal physiologic testing. The incidence of CCIS of more than 9 points, which is the primary end point in this study, was not statistically different between BFT group and control group (p = 1.000). The liquid stool incontinence in the BFT group showed a better tendency (p = 0.06) at 12 months post-SPS. Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups (p = 0.048). Also, the change of mean resting pressure (MRP) tended to be more stable in the BFT group (p = 0.074).

Conclusions

The BFT in the period of temporary stoma may be related to liquid stool incontinence at 12 months post-SPS and lead to stable MRP and better Max RST. Therefore, BFT during temporary stoma might be helpful for preventing and minimizing defecation dysfunction in high risk patients after SPS, NCT01661829).

SUBMITTER: Cho HM

PROVIDER: S-EPMC8584867 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS:Early closure (8-13 days) of a temporary stoma was compared to late closure (>?12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS:Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value?<?0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS:The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL:Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.