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Completed

NCT Number: NCT01303809

Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

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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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manukau Surgery Centre

Auckland, 2025, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Recovery After Surgey for Sleeve Gastrectomy

Other

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

Primary outcomes

  1. Length of Hospital Stay

    Time frame: 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 outcomes

  1. Complications

    Time frame: 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

  2. Readmission rates

    Time frame: 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

  3. Postoperative fatigue

    Time frame: Baseline and postoperative days 1, 7 and 14

    A measure functional recovery after surgery as measured by the validated surgical recovery scale.

  4. Compliance to the ERAS protocol

    Time frame: through to day 1 postoperatively

    Prospectively recording whether components of the ERAS programme are being carried out as per protocol.

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland Medical Research Foundation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2011
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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