Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Sponsor

University of Auckland, New Zealand (Other)

Overall Status

Completed

CT.gov ID

NCT01303809

Collaborator

Auckland Medical Research Foundation (Other)

106

Enrollment

Location

Arms

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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