Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01303809|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : May 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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.
- Length of Hospital Stay [ Time Frame: day of discharge ]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 ]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 ]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 ]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 ]Prospectively recording whether components of the ERAS programme are being carried out as per protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303809
|Manukau Surgery Centre|
|Auckland, New Zealand, 2025|