Enhanced Recovery After Laparoscopic Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-05-31

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.

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Enhanced Recovery After Surgey for Sleeve Gastrectomy

Intervention Type OTHER

Intraoperative:

1. Pre-op carbohydrate loading
2. No pre-op GIK while NBM
3. Pre-medication
4. Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
5. Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
6. Fluid restriction
7. Standardised method of anaesthesia
8. Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
9. 10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure

Postoperative:

1. Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
2. 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
3. Post operative oxygenation
4. Incentive spirometry
5. Drains (e.g. IDC) removed in recovery
6. Full mobilisation 4-8 hours post op)
7. Early Follow up

non ERAS

The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced Recovery After Surgey for Sleeve Gastrectomy

Intraoperative:

1. Pre-op carbohydrate loading
2. No pre-op GIK while NBM
3. Pre-medication
4. Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
5. Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
6. Fluid restriction
7. Standardised method of anaesthesia
8. Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
9. 10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure

Postoperative:

1. Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
2. 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
3. Post operative oxygenation
4. Incentive spirometry
5. Drains (e.g. IDC) removed in recovery
6. Full mobilisation 4-8 hours post op)
7. Early Follow up

Intervention Type OTHER

Other Intervention Names

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ERAS for sleeve gastrectomy Fast-Track for sleeve gastrectomy

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