Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients

Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.

Inclusion Criteria:

• Age: 18-75 years old
• Curative low anterior resection for rectal cancer with diverting stoma
• Stoma closure within 1 month
• Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
• No evidence of anastomotic leakage or severe stenosis

Exclusion Criteria:

• Tumor recurrence or distant metastasis
• Secondary operation with stoma
• Prior disease impairing bowel function except for rectal cancer
• Any contraindication for transanal irrigation
• Pregnant or nursing
• Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
• Cognitive or psychological disorder