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Trial details imported from ClinicalTrials.gov

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




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

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:
Pre-op carbohydrate loading
No pre-op GIK while NBM
Pre-medication
Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
Fluid restriction
Standardised method of anaesthesia
Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure
Postoperative:
Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
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
Post operative oxygenation
Incentive spirometry
Drains (e.g. IDC) removed in recovery
Full mobilisation 4-8 hours post op)
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 - The trial intends to investigate whether median length of hospital stay for patients under a standardised optimised perioperative care program is less than patients who have routine perioperative care that undergo the same operation.
Timepoint [1] 0 0
day of discharge
Secondary outcome [1] 0 0
Complications - The study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Readmission rates - The number of patients per group who represent to hospital for any reason during a 30 day period after the day of surgery
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Postoperative fatigue - A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Timepoint [3] 0 0
Baseline and postoperative days 1, 7 and 14
Secondary outcome [4] 0 0
Compliance to the ERAS protocol - Prospectively recording whether components of the ERAS programme are being carried out as per 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT01303809
Trial related presentations / publications
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

No data has been provided for results reporting
Summary results
Other publications