RecruitingPhase 4ACTRN12618001261202

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.


Sponsor

The Royal Adelaide Hospital

Enrollment

154 participants

Start Date

Aug 9, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is for adults who are having planned (elective) bowel surgery, such as removal of part of the large bowel (colorectal resection), reversal of a stoma, or formation of a new stoma. After bowel surgery, it is very common for the gut to temporarily stop working properly — a condition called postoperative ileus (POI). This causes nausea, bloating, inability to eat, and a delay in passing wind or stools, which often means a longer stay in hospital. This study tests whether giving patients a combination of two types of laxatives — a stimulant laxative (Coloxyl with Senna) and an osmotic laxative (Movicol) — after surgery helps the gut start working again sooner. This is tested within a modern 'enhanced recovery' surgical program, which already includes many strategies to reduce complications and speed recovery. Participants are randomly assigned to receive the laxative combination or standard care. You may be eligible if you are 18 or older, having elective colorectal surgery at Royal Adelaide Hospital, and are able to give consent. People with allergies to the study laxatives, severe heart failure, active inflammatory bowel disease, significant kidney or liver problems, or who are pregnant are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 (docu

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)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12618001261202


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