PicoPEX: Picolax and Pre-Operative Cardio-Pulmonary Exercise Testing

• Research type

  Research Study

• Full title

  A Study into the Effect of Mechanical Bowel Preparation on Aerobic Exercise Capacity as Measured by Cardiopulmonary Exercise Testing.

• IRAS ID

  36596

• Contact name

  Richard A Struthers

• Sponsor organisation

  Plymouth Hospitals NHS Trust

• Eudract number

  2009-016874-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Mechanical Bowel Preparation (MBP), such as Picolax©, is often given prior to major colorectal surgery. Recently critics have called for more trials to address the safety and clinical use of MBP. It can be time-consuming, expensive, unpleasant and requires hospital admission on the day prior surgery. It can be associated with dehydration and affect the salt levels within the body and requires a prolonged period of fasting. Hence, MBP may have significant effects on individual patients pre-operative fitness for surgery. An individual??s ability to exercise may reflect their heart and lung function. We can assess an individual??s ability to exercise by performing a ??Cardiopulmonary Exercise Test? (CPET) using an exercise bicycle and determine the potential impact of MBP on fitness levels. A specific package of care called ??Enhanced Recovery after Surgery? (ERAS) has been designed to promote faster recovery in patients having major surgery and has been shown to reduce complications. It avoids MBP and provides hydration and nutrition through the administration of carbohydrate drinks prior to surgery. This pilot study on healthy volunteers aims to determine whether MBP or ERAS-style preparation affect fitness judged by cardiopulmonary exercise testing. Healthy volunteers will undergo 3 Cardiopulmonary Exercise tests on three separate weekends involving a baseline test and following two interventions: (1) Mechanical Bowel Preparation (Local protocol) and (2) Enhanced Recovery after Surgery (ERAS) Guidelines. These tests will be performed in a random order. Our hypothesis is that MBP may have affect aerobic exercise capacity as measured by CPET in patients undergoing elective colorectal surgery. Any impact would be limited by avoidance of bowel preparation and administering oral carbohydrate. We will initially test this hypothesis on healthy volunteers.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/63

• Date of REC Opinion

  22 Feb 2010

• REC opinion

  Further Information Favourable Opinion