Obesity, MorbidDAYSLEEVENCT05106660
Ambulatory Laparoscopic Sleeve Gastrectomy
A study testing Ambulatory Laparoscopic Sleeve Gastrectomy and Conventional Laparoscopic Sleeve Gastrectomy in people with Obesity, Morbid, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Ambulatory Laparoscopic Sleeve Gastrectomy and Conventional Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,554 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2018to 1 Dec 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Body mass index <60
- American Anesthesiologists Association classification ≤III
- Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery
Who cannot join
- High risk for thromboembolic disease
- Has a history of major open abdominal surgery
- Bleeding disorders
- Heart disease
- Pulmonary hypertension
- Uncontrolled type 2 diabetes
- Severe obstructive sleep apnea
- Chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy
In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.
- Conditions
- Obesity, Morbid
- Being tested
- Ambulatory Laparoscopic Sleeve Gastrectomy, Conventional Laparoscopic Sleeve Gastrectomy
- Keywords
- sleeve gastrectomy, ambulatory surgery, day case surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Laparoscopic Sleeve GastrectomyProcedure or surgery
Same-day discharge
Conventional Laparoscopic Sleeve GastrectomyProcedure or surgery
Next-day discharge
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Care Laparoscopic sleeve gastrectomy | Experimental | Laparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge Receives: Procedure: Ambulatory Laparoscopic Sleeve Gastrectomy |
| Next Day Discharge Laparoscopic sleeve gastrectomy | Active comparator | Laparoscopic sleeve gastrectomy with next day discharge Receives: Procedure: Conventional Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Readmission to hospital after discharge
Measured: up to 12 months after surgery
Number of patients undergoing reoperative or revisional surgical or endoscopic intervention
Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications
Measured: up to 12 months
Hospital Transfer
Transfer of patient in Ambulatory LSG group to hospital for postop stay
Measured: up to 16 hours
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)
Measured: within 30 days
Mortality
Postoperative 30-day mortality rate
Measured: up to 30 days
Secondary outcomes (1)
Weight loss
Weight difference between baseline and follow-up visits in kilograms. Weight measured using validated, calibrated scale with minimal clothing.
Measured: 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Dec 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- None (open label)
- Enrolment
- 1,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- New You Medical Center
- Responsible party
- Principal investigator, Aayed Alqahtani, King Saud University
- Investigators
- Aayed Alqahtani, MD FRCSC, Principal investigator, New You Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106660
- Sponsor's protocol ID
- NYASCLSG001
- Acronym
- DAYSLEEVE
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Same Day vs Next Day Discharge Post Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05106660
- Acronym / sponsor ID
- DAYSLEEVE / NYASCLSG001
- Conditions
- Obesity, Morbid
- Keywords
- sleeve gastrectomy, ambulatory surgery, day case surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,554 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- New You Medical Center
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 Nov 2021 (actual)
- 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.
In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.
Detailed description
This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Care Laparoscopic sleeve gastrectomy | Experimental | Procedure: Ambulatory Laparoscopic Sleeve GastrectomyLaparoscopic sleeve gastrectomy as ambulatory care procedure with same-day discharge |
| Next Day Discharge Laparoscopic sleeve gastrectomy | Active comparator | Procedure: Conventional Laparoscopic Sleeve GastrectomyLaparoscopic sleeve gastrectomy with next day discharge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Body mass index <60
- American Anesthesiologists Association classification ≤III
- Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery
Key exclusion criteria (8 listed)
- High risk for thromboembolic disease
- Has a history of major open abdominal surgery
- Bleeding disorders
- Heart disease
- Pulmonary hypertension
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 |
|---|---|---|
| Ambulatory Laparoscopic Sleeve GastrectomySame-day discharge | Procedure or surgery | Ambulatory Care Laparoscopic sleeve gastrectomy |
| Conventional Laparoscopic Sleeve GastrectomyNext-day discharge | Procedure or surgery | Next Day Discharge Laparoscopic sleeve gastrectomy |
Primary outcome
Readmission
Time frame: up to 12 months after surgery
Readmission to hospital after discharge
Number of patients undergoing reoperative or revisional surgical or endoscopic intervention
Time frame: up to 12 months
Number of participants who underwent abdominal surgery or endoscopy for sleeve gastrectomy related complications
Hospital Transfer
Time frame: up to 16 hours
Transfer of patient in Ambulatory LSG group to hospital for postop stay
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: within 30 days
Number of participants who experienced postoperative complications (e.g. bleeding, staple line leaks, surgical site infection, etc...)
Mortality
Time frame: up to 30 days
Postoperative 30-day mortality rate
1 secondary outcome
Weight loss
Time frame: 3 months, 6 months, and 1 year
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 4 Nov 2021.
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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.
Aayed Alqahtani, MD FRCSC principal investigator
New You Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Laparoscopic Sleeve Gastrectomy and Conventional Laparoscopic Sleeve Gastrectomy in people with Obesity, Morbid, run by King Saud University at 1 site in Saudi Arabia.
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 4 inclusion and 8 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 4 Nov 2021. 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 Saudi Arabia. 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?
Readmission (time frame: up to 12 months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2021.