Impact of ERAS in LSG

Not Applicable

• Conditions: Pain, Postoperative; Nausea, Postoperative; Laparoscopic Sleeve Gastrectomy; Enhanced Recovery After Surgery; Vomiting, Postoperative
• Interventions: Other: ERAS

• Registration Number: NCT04442568
• Lead Sponsor: Umraniye Education and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-29
• Study Start: 2020-07-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS	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.

Primary Outcome Measures

Name	Time	Method
length of hospital stay	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	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	during postoperative first 30 days	number of emergency re-admission after surgery due to complications or patients discomfort