Impact of ERAS in LSG

NCT04442568 | Unknown DMC

• 1 other identifier: ERAS-LSG
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Interventions

ERAS OTHER

early mobilisation, early oral intake, early discharge

ERAS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be performed laparoscopic sleeve gastrectomy
• body mass index \> 35 with a comorbidıty or ,body mass index \> 40

You may not qualify if:

• surgery with peroperative complication
• revision surgery applications

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Related Publications (1)

• 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.

  PMID: 36576984 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Patients

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 29, 2020

Record last verified: 2020-06