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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01303809




Registration number
NCT01303809
Ethics application status
Date submitted
24/02/2011
Date registered
25/02/2011
Date last updated
25/05/2012

Titles & IDs
Public title
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Scientific title
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Secondary ID [1] 0 0
BariatricFastTrack
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Enhanced Recovery After Surgey for Sleeve Gastrectomy

Active comparator: ERAS - The perioperative management of the patients in this arm will be according to a fast-track protocol designed by the investigators. The preoperative component of this program is the same as routine practice. Intraoperative and postoperative components which are different to routine practice are as described in the intervention section. This protocol is based on current literature regarding Enhanced Recovery After Surgery (ERAS).

No intervention: non ERAS - The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.


Other interventions: Enhanced Recovery After Surgey for Sleeve Gastrectomy
Intraoperative:

1. Pre-op carbohydrate loading
2. No pre-op GIK while NBM
3. Pre-medication
4. Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
5. Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
6. Fluid restriction
7. Standardised method of anaesthesia
8. Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
9. 10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure

Postoperative:

1. Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
2. Maintenance IV fluids (60ml/hr plasmalyte to be stopped 0800 day 1 post op). Clear oral fluids 2 hours post op. Bariatric free oral fluids morning of day 1
3. Post operative oxygenation
4. Incentive spirometry
5. Drains (e.g. IDC) removed in recovery
6. Full mobilisation 4-8 hours post op)
7. Early Follow up
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of Hospital Stay
Timepoint [1] 0 0
day of discharge
Secondary outcome [1] 0 0
Complications
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Readmission rates
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Postoperative fatigue
Timepoint [3] 0 0
Baseline and postoperative days 1, 7 and 14
Secondary outcome [4] 0 0
Compliance to the ERAS protocol
Timepoint [4] 0 0
through to day 1 postoperatively

Eligibility
Key inclusion criteria
* Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
* Surgery occurs at Manukau Surgery Centre
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Surgery not occuring in Manukau Superclinic

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Auckland Medical Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The investigators wish to standardise and optimise perioperative care for consecutive patients undergoing laparoscopic sleeve gastrectomy for weight loss. The investigators will compare patients under a standardised perioperative care program to patients who undergo routine perioperative in our hospital and determine whether patients who had optimised perioperative care went home earlier and had fewer complications.
Trial website
https://clinicaltrials.gov/study/NCT01303809
Trial related presentations / publications
Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01303809