Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Conditions
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Morbid Obesity

Intervention / Treatment
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* Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERAS<br>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<br>* 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<br>* Other names: Fast-Track for sleeve gastrectomy;|
| No Intervention: non ERAS<br>The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | The study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system | 30 days | 
| 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 | 30 days | 
| Postoperative fatigue | A measure functional recovery after surgery as measured by the validated surgical recovery scale. | Baseline and postoperative days 1, 7 and 14 | 
| Compliance to the ERAS protocol | Prospectively recording whether components of the ERAS programme are being carried out as per protocol. | through to day 1 postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy