Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Morbid Obesity Clinical Trial

Official title:

Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303809
• Other study ID #: BariatricFastTrack
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: May 24, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Manukau Surgery Centre, Counties Manukau District Health Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• Enhanced Recovery After Surgey for Sleeve Gastrectomy
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

Locations

Country	Name	City	State
New Zealand	Manukau Surgery Centre	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	Auckland Medical Research Foundation

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Postoperative fatigue	A measure functional recovery after surgery as measured by the validated surgical recovery scale.	Baseline and postoperative days 1, 7 and 14	No
Secondary	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	No