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Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Enhanced Recovery After Surgey for Sleeve Gastrectomy
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manukau Surgery Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ERAS

non ERAS

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications
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
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
A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Compliance to the ERAS protocol
Prospectively recording whether components of the ERAS programme are being carried out as per protocol.

Full Information

First Posted
February 24, 2011
Last Updated
May 24, 2012
Sponsor
University of Auckland, New Zealand
Collaborators
Auckland Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01303809
Brief Title
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Official Title
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand
Collaborators
Auckland Medical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS
Arm Type
Active Comparator
Arm Description
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).
Arm Title
non ERAS
Arm Type
No Intervention
Arm Description
The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.
Intervention Type
Other
Intervention Name(s)
Enhanced Recovery After Surgey for Sleeve Gastrectomy
Other Intervention Name(s)
ERAS for sleeve gastrectomy, Fast-Track for sleeve gastrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Length of Hospital Stay
Description
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.
Time Frame
day of discharge
Secondary Outcome Measure Information:
Title
Complications
Description
The study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system
Time Frame
30 days
Title
Readmission rates
Description
The number of patients per group who represent to hospital for any reason during a 30 day period after the day of surgery
Time Frame
30 days
Title
Postoperative fatigue
Description
A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Time Frame
Baseline and postoperative days 1, 7 and 14
Title
Compliance to the ERAS protocol
Description
Prospectively recording whether components of the ERAS programme are being carried out as per protocol.
Time Frame
through to day 1 postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Manukau Surgery Centre
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
23339040
Citation
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.
Results Reference
derived

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Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

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