STIMUlant and osmotic LAXatives in Postoperative Ileus
STIMULAX Study: Open-label randomized controlled trial of a combination of simple STIMUlant and osmotic LAXatives to reduce the duration of postoperative ileus (POI) in patients undergoing colorectal surgery.
The Royal Adelaide Hospital
154 participants
Aug 9, 2018
Interventional
Conditions
Summary
Post-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this open-label randomized controlled trial is to determine the effectiveness of stimulant and osmotic laxatives on reducing the duration of postoperative ileus following bowel resection in an optimized Enhanced Recovery After Surgery (ERAS) setting. We hypothesize that in an optimized ERAS setting, using a combination of stimulant and osmotic laxatives post-operatively will result in a reduction in the duration of postoperative Ileus.
Eligibility
Plain Language Summary
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Interventions
Patients in the Intervention group will receive all the medications listed below unless specified otherwise - • Oral Coloxyl with Senna (1 tablet twice a day - Dioctyl sodium sulfosuccinate (docusate sodium) 50 mg, total sennosides (calculated as sennoside B) 8 mg.) starting the afternoon of surgery (stimulant laxative). • Oral Movicol (1 sachet = 13.7g, twice a day, powder dissolved in water) starting the afternoon of surgery (osmotic laxative). • Sodium Phosphate Enema (one enema once a day - each 118ml delivered dose contains sodium phosphate monobasic 19 g/118 mL, sodium phosphate dibasic 7 g/118 mL) from day 1 after surgery, unless left sided anastomosis is performed (osmotic laxative). Adherence to the intervention would be monitored by routine checking of medication administration charts Study medications will continue for 10 days postoperatively or until the patient has achieved the study's primary outcome.
Locations(1)
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ACTRN12618001261202