Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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
No Intervention: non ERAS
The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303809
|Manukau Surgery Centre|
|Auckland, New Zealand, 2025|