Impact of ERAS in LSG

Study Overview
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Brief Summary
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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.

Official Title
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Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy

Conditions
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Pain, Postoperative, Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Nausea, Postoperative, Vomiting, Postoperative

Intervention / Treatment
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* Other: ERAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be performed laparoscopic sleeve gastrectomy body mass index > 35 with a comorbidıty or ,body mass index > 40 Exclusion Criteria: surgery with peroperative complication revision surgery applications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERAS<br>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. | Other: ERAS<br>* early mobilisation, early oral intake, early discharge<br>|
| No Intervention: no ERAS<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | the time (in hours) from the start of surgery to the discharge of patients in both groups | 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 | 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) | postoperative 24 hours |