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Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01303809
Enrollment
106
Registered
2011-02-25
Start date
2011-05-31
Completion date
2012-05-31
Last updated
2012-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy

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.

Interventions

OTHEREnhanced 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

Sponsors

Auckland Medical Research Foundation
CollaboratorOTHER
University of Auckland, New Zealand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of Hospital Stayday of dischargeThe 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

MeasureTime frameDescription
Complications30 daysThe study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system
Readmission rates30 daysThe number of patients per group who represent to hospital for any reason during a 30 day period after the day of surgery
Postoperative fatigueBaseline and postoperative days 1, 7 and 14A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Compliance to the ERAS protocolthrough to day 1 postoperativelyProspectively recording whether components of the ERAS programme are being carried out as per protocol.

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026