Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- length of hospital stay
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ERAS
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.
Intervention: ERAS (Other)
no ERAS
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.
Outcomes
Primary Outcomes
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
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)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdullah Sisik
Assoc. Prof.
Umraniye Education and Research Hospital