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Impact of ERAS in LSG (ERAS-LSG)

Primary Purpose

Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ERAS
Sponsored by
Umraniye Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    ERAS

    no ERAS

    Arm Description

    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.

    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 Outcome Measures

    length of hospital stay
    the time (in hours) from the start of surgery to the discharge of patients in both groups
    number of emergency re-admission after surgery
    number of emergency re-admission after surgery due to complications or patients discomfort
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 18, 2020
    Last Updated
    June 24, 2020
    Sponsor
    Umraniye Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04442568
    Brief Title
    Impact of ERAS in LSG
    Acronym
    ERAS-LSG
    Official Title
    Enhanced Recovery After Surgery Protocol in Laparoscopic Sleeve Gastrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    February 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Umraniye Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Sleeve Gastrectomy, Enhanced Recovery After Surgery, Pain, Postoperative, Nausea, Postoperative, Vomiting, Postoperative

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ERAS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    no ERAS
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    ERAS
    Intervention Description
    early mobilisation, early oral intake, early discharge
    Primary Outcome Measure Information:
    Title
    length of hospital stay
    Description
    the time (in hours) from the start of surgery to the discharge of patients in both groups
    Time Frame
    till discharge, an average of 36 hours
    Title
    number of emergency re-admission after surgery
    Description
    number of emergency re-admission after surgery due to complications or patients discomfort
    Time Frame
    during postoperative first 30 days
    Title
    Score of Visual analog scale
    Description
    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)
    Time Frame
    postoperative 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Impact of ERAS in LSG

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