NCT01303809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

February 24, 2011

Last Update Submit

May 24, 2012

Conditions

Morbid Obesity

Keywords

Perioperative careFast-trackEnhanced Recovery After SurgeryERASObesityBariatric surgeryLaparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Complications

    30 days

  • Readmission rates

    30 days

  • Postoperative fatigue

    Baseline and postoperative days 1, 7 and 14

  • Compliance to the ERAS protocol

    through to day 1 postoperatively

Study Arms (2)

ERAS

ACTIVE COMPARATOR

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).

Other: Enhanced Recovery After Surgey for Sleeve Gastrectomy

non ERAS

NO INTERVENTION

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

Interventions

Enhanced Recovery After Surgey for Sleeve GastrectomyOTHER

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

Also known as: ERAS for sleeve gastrectomy, Fast-Track for sleeve gastrectomy
ERAS

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
  • Surgery occurs at Manukau Surgery Centre

You may not qualify if:

  • Surgery not occuring in Manukau Superclinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manukau Surgery Centre

Auckland, 2025, New Zealand

Location

Related Publications (1)

  • Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.

    PMID: 23339040DERIVED

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Andrew G. Hill

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

NZ(1)