Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial - Full Text View

Purpose

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.

Condition	Intervention
Morbid Obesity	Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:

Length of Hospital Stay [ Time Frame: day of discharge ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system
Readmission rates [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The number of patients per group who represent to hospital for any reason during a 30 day period after the day of surgery
Postoperative fatigue [ Time Frame: Baseline and postoperative days 1, 7 and 14 ] [ Designated as safety issue: No ]
A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Compliance to the ERAS protocol [ Time Frame: through to day 1 postoperatively ] [ Designated as safety issue: No ]
Prospectively recording whether components of the ERAS programme are being carried out as per protocol.

Enrollment:	106
Study Start Date:	May 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Other: 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 Other Names: ERAS for sleeve gastrectomy Fast-Track for sleeve gastrectomy
No Intervention: non ERAS The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.

Arms

Assigned Interventions

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).

Other: 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

Other Names:

ERAS for sleeve gastrectomy
Fast-Track for sleeve gastrectomy

No Intervention: non ERAS

The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Exclusion Criteria:

Surgery not occuring in Manukau Superclinic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303809

Locations

New Zealand
Manukau Surgery Centre
Auckland, New Zealand, 2025

Sponsors and Collaborators

University of Auckland, New Zealand

Auckland Medical Research Foundation

More Information

No publications provided by University of Auckland, New Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	SACS, Professor Andrew G. Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:	NCT01303809 History of Changes
Other Study ID Numbers:	BariatricFastTrack
Study First Received:	February 24, 2011
Last Updated:	May 24, 2012
Health Authority:	New Zealand: Manukau Surgery Centre, Counties Manukau District Health Board

Keywords provided by University of Auckland, New Zealand:

Perioperative care
Fast-track
Enhanced Recovery After Surgery
ERAS

Obesity
Bariatric surgery
Laparoscopic Sleeve Gastrectomy

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013