Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Edinburgh NHS Lothian |
---|---|
Information provided by: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT00538954 |
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.
Condition | Intervention |
---|---|
Colorectal Liver Metastases |
Drug: Post operative laxation (Magnesium Oxide) Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation Other: Standard ERAS group |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support |
Estimated Enrollment: | 64 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Follow a standard Enhanced Recovery After Surgery protocol
|
Other: Standard ERAS group |
2: Experimental
Follow a standard Enhanced Recovery After Surgery protocol and will receive 1 g of Magnesium Oxide laxative twice daily from the day after surgery until discharge
|
Drug: Post operative laxation (Magnesium Oxide)
20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
|
3: Experimental
Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days
|
Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation
Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
|
4: Experimental
Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days and will receive postoperative laxative in the form of 20 ml of Magnesium Oxide twice daily form the day after surgery until discharge
|
Drug: Post operative laxation (Magnesium Oxide)
20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation
Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Hendry, MBChB | 01312426361 | paul.hendry@ed.ac.uk |
Netherlands | |
University Hospital Maastricht | Not yet recruiting |
Maastricht, Netherlands | |
Contact: Ronald VanDam, MD R.VanDam@surgery.azm.nl | |
Sub-Investigator: Stephanie Bukkems | |
Principal Investigator: Ronald VanDam, MD | |
United Kingdom | |
Edinburgh Royal Infirmary | Recruiting |
Edinburgh, United Kingdom, EH16 4SA | |
Principal Investigator: Paul Hendry, MBChB | |
Queens Medical Centre | Not yet recruiting |
Nottingham, United Kingdom | |
Contact: Dileep N Lobo, MD Dileep.Lobo@nottingham.ac.uk |
Principal Investigator: | Paul Hendry, MBChB | University of Edinburgh |
Study ID Numbers: | UEdinburgh |
Study First Received: | October 2, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00538954 |
Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: National Health Service |
Perioperative recovery nutrition enhanced laxative |
Magnesium Oxide Neoplasm Metastasis |
Neoplasms Neoplastic Processes Pathologic Processes |
Molecular Mechanisms of Pharmacological Action Antacids Pharmacologic Actions |