Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy

• Registration Number: NCT01303809
• Lead Sponsor: University of Auckland, New Zealand

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Study Start: 2011-05
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS	Enhanced Recovery After Surgey for Sleeve Gastrectomy	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).

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay	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.

Secondary Outcome Measures

Name	Time	Method
Complications	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	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	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	through to day 1 postoperatively	Prospectively recording whether components of the ERAS programme are being carried out as per protocol.

Trial Locations

Locations (1)

Manukau Surgery Centre; 🇳🇿 Auckland, New Zealand