Clinical Evidence of Peristeen® in Low Anterior Resection Syndrome (LARS)Introduction
Colorectal cancer is the second and third most common type of cancer in women and men. Surgical resection is often
indicated, and anterior resection techniques may allow patients to keep their anal sphincter. However, functional problems
arising after surgery lead to a constellation of symptoms defined as low anterior resection syndrome (LARS) in up to 80 %of patients1. Symptoms of LARS include faecal incontinence or urgency, frequent or fragmented bowel movements,
emptying difficulties, and increased intestinal gas.
Four clinical studies have investigated transanal irrigation (TAI) with Peristeen as an alternative to conservative bowel
management (CBM) and posterior tibial nerve stimulation (PTNS) for treatment of LARS. TAI has been successfully used
to treat neurogenic bowel dysfunction in the spinal cord injured population for more than 10 years.

Clinical studies overview
Study nameStudy design
Comparator
Study size
Intervention
timeline
Primary endpoint
Secondaryendpoints
Conclusion

Rosen et al 20192
Randomized controlled trial

Enriquez-Navascues et al 20193
Randomized controlled trial

Martellucci et al 20181
Prospective interventionalstudy
TAI36
9 months

Rosen et al 20114
Prospective interventional study

TAI vs CBM
37
3 months

TAI vs PTNS
27
6 months

TAI
14
Mean 19 months (9-48)

Maximum number of defaecation
episodes during daytime at 1 monthafter ileostomy closure
Maximum number of defaecation
episodes per night,
Wexner score, LARS score and SF36
Prophylactic TAI led to asignificantly better functional
outcome compared with supportive
therapy for up to 3 months.

Reduction of at least one LARS
grade in at least 50% of patients

LARS score

Cleveland Clinic Incontinence
score

Vaizey score, EORTC QLQ-C30and VAS score

SF-36 and MSKCC BFISF-36 and Rockwood (ASCRS)QOLBoth treatments improved theLARS score in this study, but thiswas only significant in the TAI
group.

TAI appears to be an effectivetreatment for LARS and results
in a marked improvement ofcontinence and quality of life.

TAI is an effective treatment ofanterior resection syndrome andresults in a marked improvementof the continence score and QOL

Results from primary endpoints

Conclusion
The four studies demonstrate that treatment with TAI (Peristeen, Coloplast) leads to significant improvements incontinence and quality of life for patients with LARS in comparison to conservative bowel management and posterior tibial
nerve stimulation.

1 Martellucci, J. et al. Role of transanal irrigation in the treatment of anterior resection syndrome. Tech. Coloproctol. 22, 519–527 (2018).
2. Rosen, H. R. et al. Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome afterrectal resection. BJS Open bjs5.50160 (2019). doi:10.1002/bjs5.50160
3. Enriquez-Navascues, J. M. et al. A randomized trial comparing transanal irrigation and percutaneous tibial nerve stimulation in the management of low anterior resection
syndrome. Color. Dis. 1–7 (2019). doi:10.1111/codi.14870
4. Rosen, H., Robert-Yap, J., Tentschert, G., Lechner, M. & Roche, B. Transanal irrigation improves quality of life in patients with low anterior resection syndrome. Color. Dis. 13,(2011).
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