Morbid ObesityNCT01303809
Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
A study testing Enhanced Recovery After Surgey for Sleeve Gastrectomy in people with Morbid Obesity, run by University of Auckland, New Zealand at 1 site in New Zealand.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Enhanced Recovery After Surgey for Sleeve Gastrectomy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteNew Zealand
- Study dates
- May 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
- Surgery occurs at Manukau Surgery Centre
Who cannot join
- Surgery not occuring in Manukau Superclinic
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Enhanced Recovery After Surgey for Sleeve Gastrectomy
- Keywords
- Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgey for Sleeve GastrectomyOther
Also called ERAS for sleeve gastrectomy, Fast-Track 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day of discharge
Secondary outcomes (4)
Complications
The study will investigate complication rate for each group identifying incidence, type and severity of complication according to the Clavien Dindo Classification system
Measured: 30 days
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
Measured: 30 days
Postoperative fatigue
A measure functional recovery after surgery as measured by the validated surgical recovery scale.
Measured: Baseline and postoperative days 1, 7 and 14
Compliance to the ERAS protocol
Prospectively recording whether components of the ERAS programme are being carried out as per protocol.
Measured: through to day 1 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland Medical Research Foundation
- Responsible party
- Principal investigator, SACS, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303809
- Sponsor's protocol ID
- BariatricFastTrack
- Status last verified
- May 2012
- First submitted
- 24 Feb 2011
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23339040
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Laparoscopic Sleeve Gastrectomy - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01303809
- Acronym / sponsor ID
- BariatricFastTrack
- Conditions
- Morbid Obesity
- Keywords
- Perioperative care, Fast-track, Enhanced Recovery After Surgery, ERAS, Obesity, Bariatric surgery, Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Auckland Medical Research Foundation
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS | Active comparator | Other: Enhanced Recovery After Surgey for Sleeve GastrectomyThe 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). |
| non ERAS | No intervention | –The perioperative management of patients in this arm will be according to routine practice currently implemented at our institution. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing laparascopic sleeve gastrectomy for weight loss by surgeons who have agreed to participate in the study
- Surgery occurs at Manukau Surgery Centre
Key exclusion criteria (1 listed)
- Surgery not occuring in Manukau Superclinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After Surgey for Sleeve GastrectomyAlso: ERAS for sleeve gastrectomy, Fast-Track for sleeve gastrectomyIntraoperative: 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 | Other | ERAS |
Primary outcome
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.
4 secondary outcomes
Complications
Time frame: 30 days
Readmission rates
Time frame: 30 days
Postoperative fatigue
Time frame: Baseline and postoperative days 1, 7 and 14
Compliance to the ERAS protocol
Time frame: through to day 1 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
- Derived from this study: PubMed 23339040Lemanu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgey for Sleeve Gastrectomy in people with Morbid Obesity, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: day of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2012; AzTrials last refreshed its copy on 26 Oct 2026.