Laparoscopic Sleeve GastrectomyERAS-LSGNCT04442568
Impact of ERAS in LSG
A study testing ERAS in people with Laparoscopic Sleeve Gastrectomy and Enhanced Recovery After Surgery, run by Umraniye Education and Research Hospital.
Trial summary
Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Pain, Postoperative
- What is being tested?
- ERAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Jun 2021
- 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
- must be performed laparoscopic sleeve gastrectomy
- body mass index > 35 with a comorbidıty or ,body mass index > 40
Who cannot join
- surgery with peroperative complication
- revision surgery applications
About this study
Official title: Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy
Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are determined for ERAS. All patients will be checked for status of pain with VAS score, nausea and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral intake will be started in the morning of postoperative first day. The patients who provides discharge criterias will be discahrged. these criterias are; To provide adequate pain relief with paracetamol and nonsteroidal painkillers, No wound problem, No complications after surgery, Pulse rate <90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, <20 breaths / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.
Emergency admissions of the participants within a month after surgery will be recorded.
- Conditions
- Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative
- Being tested
- ERAS
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASOther
early mobilisation, early oral intake, early discharge
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Active comparator | all patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours. Receives: Other: ERAS |
| no ERAS | No intervention | all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
the time (in hours) from the start of surgery to the discharge of patients in both groups
Measured: till discharge, an average of 36 hours
number of emergency re-admission after surgery
number of emergency re-admission after surgery due to complications or patients discomfort
Measured: during postoperative first 30 days
Score of Visual analog scale
VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maxımum score 10 and higher scores mean a worse outcome)
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
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 Laparoscopic Sleeve GastrectomyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Sisik, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442568
- Sponsor's protocol ID
- ERAS-LSG
- Acronym
- ERAS-LSG
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Demirpolat MT, Sisik A, Yildirak MK, Basak F. Enhanced Recovery After Surgery Promotes Recovery in Sleeve Gastrectomy: A Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):452-458. doi: 10.1089/lap.2022.0494. Epub 2022 Dec 26.
PubMed 36576984
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04442568
- Acronym / sponsor ID
- ERAS-LSG / ERAS-LSG
- Conditions
- Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 22 Jun 2020 (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.
Patients with BMI >35 and chronic diseases or BMI >40 will be scheduled to receive Laparoscopic Sleeve Gastrectomy (LSG). Two groups are planned according to receive Enhance recovery after surgery (ERAS) protocol or not. All participants will receive standard LSG. Participants of ERAS will receive anesthesia and post-surgical nutrition protocol which are determined for ERAS. All patients will be checked for status of pain with VAS score, nausea and vomiting with PONV score at postoperative 2nd hour, 12th hour. In ERAS group liquid oral intake will be started between postoperative 2nd and 4th hours. In no ERAS group liquid oral intake will be started in the morning of postoperative first day. The patients who provides discharge criterias will be discahrged. these criterias are; To provide adequate pain relief with paracetamol and nonsteroidal painkillers, No wound problem, No complications after surgery, Pulse rate <90 beats / min, temperature ≤ 37 · 5 ° C, respiratory rate, <20 breaths / minute, To be able to mobilize easily, To be able to drink 1 liter of water after surgery.
Emergency admissions of the participants within a month after surgery will be recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients
| Arm | Type | Receives |
|---|---|---|
| ERAS | Active comparator | Other: ERASall patients in this group will be performed LSG under a specified anesthesia protocol. This protocol includes non-opioid analgesia and sedation. Also short-acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the second hour postoperatively, also will be started oral intake between second and fourth hours. |
| no ERAS | No intervention | –all patients in this group will be performed LSG under a conventional anesthesia protocol which is depended on the anesthesiologist . This protocol includes opioid analgesia and sedation. Also short and long acting anesthetic drugs will be used in this arm. The patients in this arm will be mobilized in the fourth hour postoperatively, also will be started oral intake in the next day morning after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be performed laparoscopic sleeve gastrectomy
- body mass index > 35 with a comorbidıty or ,body mass index > 40
Key exclusion criteria (2 listed)
- surgery with peroperative complication
- revision surgery applications
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 |
|---|---|---|
| ERASearly mobilisation, early oral intake, early discharge | Other | ERAS |
Primary outcome
length of hospital stay
Time frame: till discharge, an average of 36 hours
the time (in hours) from the start of surgery to the discharge of patients in both groups
number of emergency re-admission after surgery
Time frame: during postoperative first 30 days
number of emergency re-admission after surgery due to complications or patients discomfort
Score of Visual analog scale
Time frame: postoperative 24 hours
VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maxımum score 10 and higher scores mean a worse outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 36576984Demirpolat MT, Sisik A, Yildirak MK, Basak F. Enhanced Recovery After Surgery Promotes Recovery in Sleeve Gastrectomy: A Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2023 May;33(5):452-458. doi: 10.1089/lap.2022.0494. Epub 2022 Dec 26.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with Laparoscopic Sleeve Gastrectomy and Enhanced Recovery After Surgery, run by Umraniye Education and Research Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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: till discharge, an average of 36 hours). The study lists 3 primary outcomes in all. 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 NCT04442568, 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 29 Jun 2020.