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
Inclusion Criteria3
- Adult patients (aged 18 or older) from Central Adelaide Local Health Network catchment area
- Undergoing elective colorectal surgery (including large bowel resections for any indication or undergoing reversal of Hartmann's / loop-ileostomy closure or formation of stoma)
- Able to give informed consent
Exclusion Criteria18
- Under 18 years of age.
- Pregnant and lactating females.
- Allergy to Coloxyl with Senna, Movicol, Sodium Phosphate (Fleet) Enema
- Hyperphosphatemia (> 1.5 mmol/l)
- ASA >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
- Active inflammatory bowel disease
- Colonic Motility disorders (Congenital megacolon, imperforate anus)
- Moderate-Severe Congestive heart failure
- Patients on calcium channel blockers or diuretics with significant electrolyte abnormalities
- Patients with established Ileus as suggested by needing to place a nasogastric tube for decompression, vomiting and unable to tolerate food
- Intestinal obstruction or perforation
- Patients with abdominal pain of unknown cause
- Moderate to severe renal impairment (eGFR < 45 based on two samples a minimum 90d apart).
- GFR will be calculated using the Cockcroft Gault equation for creatinine clearance:
- CrCl ml/min = [140-age(years)] x bodyweight (kg) / R x serum creatinine (micromol/L)
- R = 0.815 for males, 0.85 for females
- Severe hepatic impairment (Child-Pugh class C )
- Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment and/or language barrier.
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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