Impact of ERAS in LSG

Pain, Postoperative Clinical Trial

— ERAS-LSG  

Official title:

Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04442568
• Other study ID #: ERAS-LSG
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• must be performed laparoscopic sleeve gastrectomy

• body mass index > 35 with a comorbidity or ,body mass index > 40

Exclusion Criteria:

• surgery with peroperative complication

• revision surgery applications

Related Conditions & MeSH terms

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

Intervention

Other:
• ERAS
early mobilisation, early oral intake, early discharge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Score of Visual analog scale	VAS scores that evaluate postoperative pain in both groups will be compared (minimum score 0, maximum score 10 and higher scores mean a worse outcome)	postoperative 24 hours