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Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

NCT01303809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2012-05-25

No results posted yet for this study

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.

Conditions

  • Morbid Obesity

Interventions

OTHER

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

Sponsors & Collaborators

  • Auckland Medical Research Foundation

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303809 on ClinicalTrials.gov