Records View

Effects of chewing gum during pre-anesthetic fasting on preoperative anxiety and postoperative recovery in patients undergoing laparoscopic gynecological surgery with ERAS protocol

Status Approved

  • First Submitted Date

    2020/12/03

  • Registered Date

    2020/12/29

  • Last Updated Date

    2021/09/07

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005714
    Unique Protocol ID SMC 2020-10-058-002
    Public/Brief Title Effects of chewing gum during pre-anesthetic fasting on preoperative anxiety and postoperative recovery in patients undergoing laparoscopic gynecological surgery
    Scientific Title Effects of chewing gum during pre-anesthetic fasting on preoperative anxiety and postoperative recovery in patients undergoing laparoscopic gynecological surgery with ERAS protocol
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SMC 2020-10-058-002
    Approval Date 2020-12-03
    Institutional Review Board Name Samsung medical center, institutional review board
    Institutional Review Board Address 81, Irwon-ro, Gangnam-gu, Seoul
    Institutional Review Board Telephone 02-3410-2973
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jeongjin MIn
    Title Assistant professor
    Telephone +82-2-3410-5257
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
    Contact Person for Public Queries
    Name Yujeong Bang
    Title Clinical fellow
    Telephone +82-2-3410-6580
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
    Contact Person for Updating Information
    Name Yujeong Bang
    Title Clinical fellow
    Telephone +82-2-3410-6580
    Affiliation Samsung Medical Center
    Address (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2021-01-04 Actual
    Target Number of Participant 104
    Primary Completion Date 2021-08-13 , Actual
    Study Completion Date 2021-08-13 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2021-01-04 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
    Project ID SMC 2020-10-058-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    In the case of patients undergoing general anesthesia, fasting of 8 hours of solid food, 6 hours of light meals, and 2 hours of clear drink is strictly followed in accordance with the guidelines of the American Society of Anesthesiology to prevent complications such as regurgitation of gastric juice and pulmonary aspiration. Currently, the concept of early recovery after surgery (ERAS) was introduced for early recovery after surgery in various surgical patients. In accordance with this guideline, a clear liquid should be consumed 2 hours before anesthesia, and carbohydrate beverages should be administered during the fasting period. 
    Oral carbohydrate loading in the preoperative period minimizes the side effects such as catabolic state and delay in recovery due to excessive fasting can be prevented, and promotes the patient's satisfaction and well-being. Oral carbohydrate loading is recommended to administer 800ml to 400ml of carbohydrate beverages up to 2 hours before surgery as a standard practice. The ERAS Society has suggested that chewing gum during the fasting period before surgery also has a positive effect and can be recommended. Studies have recently been published that chewing gum in the preoperative fasting period does not affect gastric volume and acidity in patients before surgery, lowers patient anxiety, and reduces side effects from fasting. We recently conducted study in the gynecologic patients of our hospital that chewing gum during preoperative period has an significant effect in reducing preoperative anxiety and improving postoperative recovery (SMC 2019-05-168-001). Similar to the previous study results, no adverse events were reported. 
     At present, gynecology department of our hospital decided to apply the ERAS protocol  to patients who are scheduled to undergo surgery at the gynecological cancer center, and accordingly, they will take a carbohydrate drink during the fasting time before surgery. 
     This study is a serial study (SMC 2019-05-168-001) on the anxiety reduction effect of chewing gum within the preoperative fasting time. Patients participating in the altered treatment protocol of  gynecology were set as a control group and the fasting period before surgery. We would like to investigate whether there is an effect of reducing anxiety and discomfort before surgery by additionally performing a sham feeding with chewing gum. In addition, we would like to compare whether there is any difference in recovery of gastrointestinal function, diet resumption, postoperative recovery, and well-being between each group.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    ① The patient is assigned to the Experimentand control groups on a random basis on the eve of the operation by independent gynecologist. All patients  strictly observes the fast times of eight hours of solid form, six hours of fluid and two hours of clear fluid in a traditional way. 
    ② The patients in the control group (carbohydrate group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO at 5am. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery.
    ③ The patients in the test group (gum group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery.The test group (Group G) is  allowed to chew gum that is distributed freely during fast time, while follow the fasting protocol.
    ④	There is no intervention other than chewing gum during fast times between the two groups of patients, and subsequent anesthesia and pre-anesthesia examinations will be the same.
    Number of Arms 2
    Arm 1

    Arm Label

    Carbohydrate group

    Target Number of Participant

    52

    Arm Type

    No intervention

    Arm Description

    The patients in the control group (carbohydrate group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery.
    Arm 2

    Arm Label

    gum group

    Target Number of Participant

    52

    Arm Type

    No intervention

    Arm Description

    The patients in the test group (gum group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO at 5am. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery.
    The test group (Group G) is  allowed to chew gum that is distributed freely during fast time, while follow the fasting protocol.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F41.9)Anxiety disorder, unspecified 

    Test Anxiety Questionnaire Enhanced Recovery After Surgery Recovery Period, Anesthesia Perioperative Period
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    19Year~69Year

    Description

    (1) ASA class I-III adult patient (age 19 and under 70) 
    (2) Patients undergoing  the laparoscopic gynecological surgery
    Exclusion Criteria
    (1) Pediatric (under 19) 
    (2) Old age (over 69) 
    (2) Pregnant and nursing mothers 
    (3) Patients with unstable vital signs 
    (4) Patients who are at high risk of aspiration 
    persons with a BMI of 30 or more, gastroesophageal reflux, chronic renal failure, oesophageal structures, achalasia, enteropaties, diabets mellitus, and with a history of gastrointestinal tumors; 
    (5) Any medical history that could effect GI motility 
    (6) Patients with liver and kidney disease 
    (6) Emergency surgery. 
    (7) Patients who do not agree to participate in the study
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Pre-operative anxiety
    Timepoint
    proir to induction of general anesthesia
    Secondary Outcome(s) 1
    Outcome
    Symptoms related to anxiety
    Timepoint
    inhospital period
    Secondary Outcome(s) 2
    Outcome
    Recovery or bowel function
    Timepoint
    inhospital period
    Secondary Outcome(s) 3
    Outcome
    bowel complication
    Timepoint
    inhospital period
    Secondary Outcome(s) 4
    Outcome
    Quality of recovery questionnaire ( with QoR 15 score)
    Timepoint
    inhospital period
    Secondary Outcome(s) 5
    Outcome
    gastric volume with gastric sonography
    Timepoint
    inhospital period
    Secondary Outcome(s) 6
    Outcome
    Gastric fluid  volume and acidity
    Timepoint
    inhospital period
    Secondary Outcome(s) 7
    Outcome
    intraoperative outcomes
    Timepoint
    intraoperative period
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 11
    Way of Sharing Available on Request
    (gagreflex.bang@gmail.com)
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동